https://www.benzinga.com/views/taxonomy/term/59 en https://www.benzinga.com/markets/biotech/26/04/52064053/intellia-therapeutics-fda-rolling-application-for-gene-therapy-puts-hype-to-test?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p><strong>Intellia Therapeutics Inc.</strong> <a class="ticker-link" data-ticker="NTLA" data-exchange="NASDAQ" href="https://www.benzinga.com/quote/NTLA" target="_blank" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/NTLA">NTLA</a>)</a> shares are up on Monday after the company announced a rolling BLA submission to the FDA for its gene-editing therapy, lonvo-z (NTLA-2002), which is aimed at <a href="https://www.benzinga.com/general/biotech" target="_blank" rel="noreferrer noopener">treating hereditary angioedema</a>.</p> <p>The news comes <a target="_blank" href="https://www.benzinga.com/pressreleases/26/04/g52057119/intellia-therapeutics-reports-positive-phase-3-results-in-hereditary-angioedema-marking-a-global-f" rel="noreferrer noopener">following positive topline</a> results from the Phase 3 HAELO trial.</p> <h2 class="wp-block-heading">Efficacy Data Show Significant Attack Reduction</h2> <p>80 patients were enrolled, with 52 receiving Lonvo-Z and 28 receiving a placebo. The trial met its primary endpoint.</p> <p>For the six-month efficacy evaluation period (weeks 5 to 28), a one-time infusion of lonvo-z reduced attacks by 87% versus placebo, with a mean monthly attack rate of 0.26 in the lonvo-z arm compared with 2.10 in the placebo arm.</p> <p>The trial met all of its key secondary endpoints with statistical significance.</p> <p>These included a 62% rate of patients who were entirely attack-free and therapy-free in the Lonvo-Z arm for the six-month efficacy evaluation period, compared with 11% of <a target="_blank" href="https://www.benzinga.com/news/fda/26/01/50167197/intellia-moves-forward-as-fda-removes-trial-hold-for-rare-disorder" rel="noreferrer noopener">patients in the placebo arm</a>.</p> <p>Favorable safety and tolerability data were observed for lonvo-z.</p> <p>All TEAEs reported as of the data cutoff (February ...</p><p><a href=https://www.benzinga.com/markets/biotech/26/04/52064053/intellia-therapeutics-fda-rolling-application-for-gene-therapy-puts-hype-to-test?utm_source=benzinga_taxonomy&amp;utm_medium=rss_feed_free&amp;utm_content=taxonomy_rss&amp;utm_campaign=channel alt=Intellia Therapeutics FDA Rolling Application For Gene Therapy Puts Hype To Test>Full story available on Benzinga.com</a></p> benzai Biotech News NTLA why it's moving Health Care FDA Top Stories Movers Trading Ideas General NTLA News Biotech Health Care FDA Top Stories Movers Trading Ideas General Benzinga Mon, 27 Apr 2026 14:07:20 +0000 Vandana Singh 52064053 at https://www.benzinga.com https://www.benzinga.com/news/health-care/26/04/52059813/south-carolina-declares-end-to-largest-us-measles-outbreak-since-elimination?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p>South Carolina health officials have declared an end to a measles outbreak that infected 997 people over six months, making it the largest single-location outbreak in the U.S. since the disease was declared eliminated, Reuters reported Sunday.</p> <p>The outbreak began in October 2025 and spread primarily through unvaccinated school-age children, according to the South Carolina Department of Public Health. The last case was reported on March 15, after which state officials waited 42 days, twice the virus&#8217;s maximum incubation period, before formally declaring it over.</p> <p>Of the 997 cases, 932 occurred in people who had never been vaccinated. Spartanburg County accounted for more than 90% of infections. Children aged 5 to 17 made up the largest share, with 639 cases. The outbreak cost the state an estimated $2.1 million and led to 874 students being quarantined across 33 schools.</p> <div class="bz-read-next-block"<br /> data-variant="card"<br /> ...</div><p><a href=https://www.benzinga.com/news/health-care/26/04/52059813/south-carolina-declares-end-to-largest-us-measles-outbreak-since-elimination?utm_source=benzinga_taxonomy&amp;utm_medium=rss_feed_free&amp;utm_content=taxonomy_rss&amp;utm_campaign=channel alt=South Carolina Declares End To Largest US Measles Outbreak Since Elimination>Full story available on Benzinga.com</a></p> CDC Government merck News Regulations Health Care FDA News Government Regulations Health Care FDA Benzinga Mon, 27 Apr 2026 12:35:34 +0000 Tanya Rawat 52059813 at https://www.benzinga.com https://www.benzinga.com/news/fda/26/04/52042968/fda-flags-high-risk-recall-for-tandem-diabetes-mobi-pumps?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p>The U.S. Food and Drug Administration has <a target="_blank" href="https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/insulin-pump-correction-tandem-diabetes-care-issues-correction-tandem-mobi-insulin-pumps" rel="noreferrer noopener">classified</a> a corrective action involving insulin pumps from <strong>Tandem Diabetes Care Inc.</strong> <a href="https://www.benzinga.com/quote/TNDM" target="_blank" class="ticker-link" data-ticker="TNDM" data-exchange="NASDAQ" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/TNDM">TNDM</a>)</a> as a Class I recall, the agency&#039;s most serious designation, citing risks of serious injury or death if the issue is not addressed.</p> <p>The recall does not involve removing products from the market. Instead, it focuses on correcting affected devices currently in use.</p> <h2 class="wp-block-heading">Device Overview</h2> <p>Tandem&#039;s insulin pumps are battery-operated devices designed to deliver both basal and bolus insulin through a motor-driven system, using a cartridge and infusion set to administer insulin subcutaneously.</p> <div class="bz-read-next-block"<br /> data-variant="card"<br /> data-news-mode="manual" <p> ></p> <p> <strong><br /> Read Also:<br /> <a href="https://www.benzinga.com/analyst-stock-ratings/initiation/26/04/51600245/diabetes-focused-minimed-recovery-story-builds-as-pipeline-improves" target="_blank" rel="noopener"><br /> Also Read: Diabetes Focused MiniMed Recovery Story Builds As Pipeline Improves</a><br /> </strong> </p> </div> <h2 class="wp-block-heading">Affected Devices And Required Action</h2> <p>The FDA said Tandem issued an urgent medical device correction for its Mobi insulin pumps running ...</p><p><a href=https://www.benzinga.com/news/fda/26/04/52042968/fda-flags-high-risk-recall-for-tandem-diabetes-mobi-pumps?utm_source=benzinga_taxonomy&amp;utm_medium=rss_feed_free&amp;utm_content=taxonomy_rss&amp;utm_campaign=channel alt=FDA Flags High-Risk Recall For Tandem Diabetes Mobi Pumps>Full story available on Benzinga.com</a></p> Large Cap News Stories That Matter TNDM TNDM Health Care FDA General TNDM US64128B1089 TNDM US64128B1089 News Large Cap Health Care FDA General Benzinga Fri, 24 Apr 2026 18:18:16 +0000 Vandana Singh 52042968 at https://www.benzinga.com https://www.benzinga.com/news/fda/26/04/52028176/grace-therapeutics-stock-falls-as-fda-declines-to-approve-brain-hemorrhage-drug?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p><strong>Grace Therapeutics Inc.</strong> <a href="https://www.benzinga.com/quote/GRCE" target="_blank" class="ticker-link" data-ticker="GRCE" data-exchange="NASDAQ" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/GRCE">GRCE</a>)</a> shares are down during Friday&#8217;s premarket session following a <a target="_blank" href="https://www.benzinga.com/pressreleases/26/04/g52009531/grace-therapeutics-provides-regulatory-update-on-new-drug-application-for-gtx-104" rel="noreferrer noopener">regulatory update regarding</a> its New Drug Application (NDA) for GTx-104.</p> <p>The stock&#8217;s decline comes as the FDA issued a Complete Response Letter citing outstanding items related to Chemistry, Manufacturing, and Controls, and non-clinical <a target="_blank" href="https://www.benzinga.com/general/biotech/25/02/43600505/small-cap-grace-therapeutics-touts-positive-data-from-brain-hemorrhage-study" rel="noreferrer noopener">sections of the application</a>.</p> <h2 class="wp-block-heading">FDA Strikes Off Grace Therapeutics Drug</h2> <p>The FDA&#8217;s Complete Response Letter indicates that Grace Therapeutics must address specific Chemistry, Manufacturing, and Controls issues before resubmitting its NDA for GTx-104, a treatment for aneurysmal <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">subarachnoid hemorrhage (aSAH)</a>.</p> <p>The cited items are related to leachables data for product packaging, non-clinical product toxicology risk assessments, and product manufacturing deficiencies at the contract manufacturing organization.</p> <p>The late-stage biopharma company plans to request a Type A meeting with the FDA to clarify the next steps.</p> <p>The FDA did not request <a target="_blank" href="https://www.benzinga.com/general/biotech" rel="noreferrer noopener">additional clinical data</a>.</p> <p>&#8220;We are confident in the robust data package supporting our NDA submission, and that the ...</p><p><a href=https://www.benzinga.com/news/fda/26/04/52028176/grace-therapeutics-stock-falls-as-fda-declines-to-approve-brain-hemorrhage-drug?utm_source=benzinga_taxonomy&amp;utm_medium=rss_feed_free&amp;utm_content=taxonomy_rss&amp;utm_campaign=channel alt=Grace Therapeutics Stock Falls As FDA Declines To Approve Brain Hemorrhage Drug>Full story available on Benzinga.com</a></p> benzai Biotech GRCE News why it's moving Health Care FDA Movers Trading Ideas General GRCE News Biotech Health Care FDA Movers Trading Ideas General Benzinga Fri, 24 Apr 2026 13:30:24 +0000 Vandana Singh 52028176 at https://www.benzinga.com https://www.benzinga.com/news/fda/26/04/52026846/abbvie-faces-fda-rejection-on-manufacturing-issues-for-wrinkle-drug?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p><strong>AbbVie Inc. </strong><a href="https://www.benzinga.com/quote/ABBV" target="_blank" class="ticker-link" data-ticker="ABBV" data-exchange="NYSE" rel="noopener">(NYSE:<a class="ticker" href="https://www.benzinga.com/quote/ABBV">ABBV</a>)</a> shares are down during Friday&#8217;s premarket session <a target="_blank" href="https://www.benzinga.com/pressreleases/26/04/n52015953/abbvie-provides-update-on-trenibotulinumtoxine-trenibote-biologics-license-application-in-the-u-s" rel="noreferrer noopener">following a Complete Response Letter</a> (CRL) from the FDA regarding the Biologics License Application for trenibotulinumtoxinE (TrenibotE).</p> <p>The letter requested additional information about manufacturing processes but did not raise any <a target="_blank" href="https://www.benzinga.com/news/health-care/26/02/50846301/gilgamesh-withdraws-patent-fight-against-enveric-after-1-2-billion-abbvie-deal-ceo-says-key-drug-claims-now-uncontested" rel="noreferrer noopener">safety or efficacy concerns</a>.</p> <h2 class="wp-block-heading">FDA Rejection Hits AbbVie Wrinkle Drug Filing</h2> <p>The FDA&#8217;s CRL does not require additional clinical studies, and AbbVie is confident in addressing the agency&#8217;s feedback promptly.</p> <p>The company expects to submit a thorough response in the coming months, while regulatory reviews for TrenibotE in other countries are ongoing.</p> <p>TrenibotE is a first-in-class <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">botulinum neurotoxin serotype E</a> characterized by a rapid onset of action as early as 8 hours after administration (the earliest assessment time) and a short duration of effect of 2-3 weeks.</p> <p>In April 2025, the U.S.-based large-cap drug maker <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/n44977545/abbvie-submits-biologics-license-application-to-u-s-fda-for-trenibotulinumtoxine-trenibote-for-the" rel="noreferrer noopener">submitted the FDA application</a> for <em>TrenibotE for </em>moderate to severe glabellar lines (frown lines).</p> <div class="bz-read-next-block"<br /> data-variant="card"<br /> data-news-mode="manual" <p> ></p> <p> <strong><br /> Read Also:<br /> <a href="https://www.benzinga.com/news/fda/26/02/50746087/fda-approval-for-abbvie-astrazenecas-combination-treatment-could-set-new-standard-for-slow-growing-blood-cancer" target="_blank" rel="noopener"><br /> Also Read: FDA Approval For AbbVie/AstraZeneca&#039;s Combination Treatment Could Set New Standard For ...</a></strong></p></div><p><a href=https://www.benzinga.com/news/fda/26/04/52026846/abbvie-faces-fda-rejection-on-manufacturing-issues-for-wrinkle-drug?utm_source=benzinga_taxonomy&amp;utm_medium=rss_feed_free&amp;utm_content=taxonomy_rss&amp;utm_campaign=channel alt=AbbVie Faces FDA Rejection On Manufacturing Issues For Wrinkle Drug>Full story available on Benzinga.com</a></p> ABBV ABBV Biotech Large Cap News Health Care FDA Top Stories Movers General ABBV ABBV News Biotech Large Cap Health Care FDA Top Stories Movers General Benzinga Fri, 24 Apr 2026 12:46:27 +0000 Vandana Singh 52026846 at https://www.benzinga.com https://www.benzinga.com/markets/equities/26/04/52022779/tivic-health-systems-tivc-stock-surges-over-24-after-hours-heres-what-is-happening?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p><strong>Tivic Health Systems Inc.</strong> <a class="ticker-link" data-ticker="TIVC" data-exchange="NASDAQ" href="https://www.benzinga.com/quote/TIVC" target="_blank" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/TIVC">TIVC</a>)</a> shares jumped 24.10% to $1.39 in after-hours trading after the San Antonio-based company announced a full corporate rebrand to <strong>Valion Bio, Inc.</strong>, with its ticker shifting to VBIO at market open on April 28.</p> <h2 class="wp-block-heading">Strategic Transformation Behind The Rebrand</h2> <p>The rebrand caps a fundamental strategic pivot, exiting consumer medical devices and repositioning around Entolimod&#x2122;, a TLR5 agonist developed as a medical countermeasure for acute radiation syndrome, with <strong>Food and Drug Administration</strong> Fast Track and Orphan Drug designations. The asset is advancing under the FDA&#8217;s Animal Rule pathway, which permits approval based on animal efficacy data when human trials are not feasible or ethical.</p> <p>Valion Bio is actively engaging the Biomedical Advanced Research and Development Authority (BARDA), the Defense Threat Reduction Agency (DTRA), and the National Institute of Allergy and ...</p><p><a href=https://www.benzinga.com/markets/equities/26/04/52022779/tivic-health-systems-tivc-stock-surges-over-24-after-hours-heres-what-is-happening?utm_source=benzinga_taxonomy&amp;utm_medium=rss_feed_free&amp;utm_content=taxonomy_rss&amp;utm_campaign=channel alt=Tivic Health Systems (TIVC) Stock Surges Over 24% After Hours: Here&#039;s What Is Happening>Full story available on Benzinga.com</a></p> benzai Biotech Equities News TIVC Why is it moving? FDA Markets General TIVC News Biotech Equities FDA Markets General Benzinga Fri, 24 Apr 2026 08:17:18 +0000 Mohd Haider 52022779 at https://www.benzinga.com https://www.benzinga.com/news/health-care/26/04/52003687/fda-approval-broadens-dupixent-use-while-sanofi-posts-earnings-beat?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p>French drugmaker<strong> Sanofi SA&nbsp;</strong><a href="https://www.benzinga.com/quote/SNY" target="_blank" class="ticker-link" data-ticker="SNY" data-exchange="NASDAQ" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/SNY">SNY</a>)</a> and its partner <strong>Regeneron Pharmaceuticals Inc.</strong> <a href="https://www.benzinga.com/quote/REGN" target="_blank" class="ticker-link" data-ticker="REGN" data-exchange="NASDAQ" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/REGN">REGN</a>)</a> on Wednesday secured U.S. Food and Drug Administration (FDA) approval for <a target="_blank" href="https://www.benzinga.com/markets/earnings/26/01/50221915/sanofi-warns-dupixent-is-too-big-to-replace-as-patent-clock-ticks" rel="noreferrer noopener">Dupixent (dupilumab)</a> for uncontrolled chronic spontaneous urticaria (CSU) in young children.</p> <h2 class="wp-block-heading">Sanofi, Regeneron Win FDA Approval</h2> <p>CSU is a skin condition characterized by itchy hives, swelling (angioedema), or both, appearing almost daily for six weeks or longer without an identifiable trigger.</p> <p>The <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2026/2026-04-22-21-30-00-3279472" rel="noreferrer noopener">approval</a> covers children aged two to 11 years with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 antihistamine (H1AH) treatment, expanding the previous <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2025/2025-04-18-15-15-00-3064131" rel="noreferrer noopener">approval</a> for Dupixent in adults and adolescents aged 12 years and older with CSU.</p> <p>In February, the FDA approved<strong> </strong>Dupixent for treating allergic fungal rhinosinusitis in patients aged six years and older with ...</p><p><a href=https://www.benzinga.com/news/health-care/26/04/52003687/fda-approval-broadens-dupixent-use-while-sanofi-posts-earnings-beat?utm_source=benzinga_taxonomy&amp;utm_medium=rss_feed_free&amp;utm_content=taxonomy_rss&amp;utm_campaign=channel alt=FDA Approval Broadens Dupixent Use While Sanofi Posts Earnings Beat>Full story available on Benzinga.com</a></p> Biotech Earnings Large Cap News REGN SNY why it's moving Guidance Health Care FDA Top Stories Movers General REGN US75886F1075 SNY US80105N1054 News Earnings Biotech Large Cap Guidance Health Care FDA Top Stories Movers General Benzinga Thu, 23 Apr 2026 15:02:49 +0000 Vandana Singh 52003687 at https://www.benzinga.com https://www.benzinga.com/news/fda/26/04/51963690/sanofi-eyes-first-on-body-injector-cancer-therapy-as-fda-delays-decision?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p>The U.S. Food and Drug Administration (FDA) on Wednesday delayed its decision on <strong>Sanofi SA&#8217;</strong>s <a href="https://www.benzinga.com/quote/SNY" target="_blank" class="ticker-link" data-ticker="SNY" data-exchange="NASDAQ" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/SNY">SNY</a>)</a> subcutaneous Sarclisa formulation while separately broadening the eligible patient population for Tzield.</p> <h2 class="wp-block-heading">FDA Extends Sarclisa SC Review Timeline</h2> <p>The FDA has <a target="_blank" href="https://www.sanofi.com/en/media-room/press-releases/2026/2026-04-22-05-00-00-3278646" rel="noreferrer noopener">pushed</a> its target action date for the biologics license application for Sarclisa (isatuximab-irfc) subcutaneous (SC) formulation by up to three months.</p> <p>The agency now expects to deliver its decision by July 23.</p> <p>The application covers the use of Sarclisa SC in combination with standard-of-care regimens for <a target="_blank" href="https://www.benzinga.com/general/biotech" rel="noreferrer noopener">patients with multiple myeloma</a> across all currently approved U.S. indications of the intravenous version.</p> <p>If cleared, the subcutaneous version could become the first anticancer treatment delivered via an on-body injector, offering a potentially more convenient administration method.</p> <div class="bz-read-next-block"<br /> data-variant="card"<br /> data-news-mode="manual" <p> ...</p></div><p><a href=https://www.benzinga.com/news/fda/26/04/51963690/sanofi-eyes-first-on-body-injector-cancer-therapy-as-fda-delays-decision?utm_source=benzinga_taxonomy&amp;utm_medium=rss_feed_free&amp;utm_content=taxonomy_rss&amp;utm_campaign=channel alt=Sanofi Eyes First On-Body Injector Cancer Therapy As FDA Delays Decision>Full story available on Benzinga.com</a></p> Biotech Large Cap News SNY Health Care FDA Top Stories General SNY US80105N1054 News Biotech Large Cap Health Care FDA Top Stories General Benzinga Wed, 22 Apr 2026 11:35:51 +0000 Vandana Singh 51963690 at https://www.benzinga.com https://www.benzinga.com/markets/equities/26/04/51960000/kyverna-therapeutics-kytx-stock-surges-24-after-hours-why-is-it-moving?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p><strong>Kyverna Therapeutics Inc. </strong><a href="https://www.benzinga.com/quote/KYTX" target="_blank" class="ticker-link" data-ticker="KYTX" data-exchange="NASDAQ" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/KYTX">KYTX</a>)</a> shares jumped 24% after hours to $12.04 Tuesday after releasing positive registrational trial results for miv-cel in stiff person syndrome at the American Academy of Neurology Annual Meeting in Chicago.</p> <p>Miv-cel, the single-dose CAR T-cell therapy met its primary endpoint, delivering a statistically significant 46% median improvement in the Timed 25-Foot Walk at 16 weeks. </p> <p>All 26 patients discontinued chronic immunotherapies and 81% achieved a clinically meaningful improvement, with at least a 20% improvement from baseline in walking speed.</p> <h2 class="wp-block-heading">No Approved Therapies</h2> <p>Kyverna Therapeutics stated SPS affects roughly 6,000 U.S. patients with no <strong>Food and Drug Administration</strong>-approved treatments currently available.</p> <p>CEO <strong>Warner Biddle</strong> said, "We see compelling evidence that a one-time therapy can reset the immune system, ...</p><p><a href=https://www.benzinga.com/markets/equities/26/04/51960000/kyverna-therapeutics-kytx-stock-surges-24-after-hours-why-is-it-moving?utm_source=benzinga_taxonomy&amp;utm_medium=rss_feed_free&amp;utm_content=taxonomy_rss&amp;utm_campaign=channel alt=Kyverna Therapeutics (KYTX) Stock Surges 24% After Hours: Why Is It Moving?>Full story available on Benzinga.com</a></p> Biotech Earnings Equities KYTX News Why is it moving? FDA After-Hours Center Markets General KYTX News Earnings Biotech Equities FDA After-Hours Center Markets General Benzinga Wed, 22 Apr 2026 06:44:08 +0000 Mohd Haider 51960000 at https://www.benzinga.com https://www.benzinga.com/news/health-care/26/04/51938443/federal-court-reportedly-halts-kennedys-vaccine-panel-putting-covid-flu-and-rsv-shots-at-risk?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p>A federal court order has halted the work of a key U.S. vaccine advisory panel, disrupting the system that guides COVID-19, flu and other immunization recommendations and raising uncertainty over insurance coverage for newly approved vaccines, according to Reuters reporting on Tuesday.</p> <p>U.S. District <strong>Judge Brian Murphy </strong>of the District of Massachusetts issued a ruling that paused the <strong>Advisory Committee on Immunization Practices</strong> (ACIP), finding that most members appointed under Health and Human Services Secretary<strong> Robert F. Kennedy Jr.</strong> were likely unqualified. The order effectively blocks the panel from issuing new recommendations while litigation proceeds and reinstates prior immunization guidance on an interim basis.</p> <h2 class="wp-block-heading"><strong>A Systematic Dismantling</strong></h2> <p>Kennedy dismissed every sitting ACIP member in June 2025, replacing them with individuals skeptical of COVID-19 vaccine mandates, then added five more without rigorous vetting in September. Trump announced on Truth Social a reduction in recommended vaccines from 72 to 11. <strong>Pfizer Inc. </strong><a class="ticker-link" data-ticker="PFE" data-exchange="NYSE" href="https://www.benzinga.com/quote/PFE" target="_blank" rel="noopener">(NYSE:<a class="ticker" href="https://www.benzinga.com/quote/PFE">PFE</a>)</a> CEO <strong>Albert Bourla</strong> called<a href="https://www.benzinga.com/news/health-care/26/03/51291664/federal-judge-flags-legal-flaws-in-rfk-jr-s-vaccine-overhaul"> Kennedy&#8217;s stance &#8220;anti-science.&#8221;</a></p> <h2 class="wp-block-heading"><strong>Autumn Vaccine Season At Risk</strong></h2> <p>In a normal year, ACIP reviews and updates recommendations for COVID and flu shots at its June meeting. Seasonal flu vaccines carry a long-standing universal recommendation and may not require ...</p><p><a href=https://www.benzinga.com/news/health-care/26/04/51938443/federal-court-reportedly-halts-kennedys-vaccine-panel-putting-covid-flu-and-rsv-shots-at-risk?utm_source=benzinga_taxonomy&amp;utm_medium=rss_feed_free&amp;utm_content=taxonomy_rss&amp;utm_campaign=channel alt=Federal Court Reportedly Halts Kennedy&#039;s Vaccine Panel, Putting COVID, Flu And RSV Shots At Risk>Full story available on Benzinga.com</a></p> Government GSK MRK MRNA News PFE Health Care Politics FDA Legal GSK US37733W1053 MRK US58933Y1055 PFE US7170811035 MRNA US56804Q1022 News Government Health Care Politics FDA Legal Benzinga Tue, 21 Apr 2026 13:31:16 +0000 Tanya Rawat 51938443 at https://www.benzinga.com https://www.benzinga.com/markets/equities/26/04/51910727/enveric-biosciences-surges-over-90-other-psychedelic-stocks-soar-in-monday-pre-market-whats-goin?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p>Shares of&nbsp;<strong>Enveric BioSciences</strong>&nbsp;<a class="ticker-link" data-ticker="ENVB" data-exchange="NASDAQ" href="https://www.benzinga.com/quote/ENVB" target="_blank" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/ENVB">ENVB</a>)</a> added over 92% in the premarket trading session on Monday. <strong>AtaiBeckley Inc</strong>&nbsp;<a class="ticker-link" data-ticker="ATAI" data-exchange="NASDAQ" href="https://www.benzinga.com/quote/ATAI" target="_blank" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/ATAI">ATAI</a>)</a> surged by 28.1%, while <strong>Compass Pathways</strong>&nbsp;<a class="ticker-link" data-ticker="CMPS" data-exchange="NASDAQ" href="https://www.benzinga.com/quote/CMPS" target="_blank" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/CMPS">CMPS</a>)</a> and <strong>Definium Therapeutics</strong>&nbsp;<a class="ticker-link" data-ticker="DFTX" data-exchange="NASDAQ" href="https://www.benzinga.com/quote/DFTX" target="_blank" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/DFTX">DFTX</a>)</a> saw their shares ascend by 26.1% and 14.6%, respectively, after President <strong>Donald Trump</strong> issued an executive order on Saturday instructing health regulators to hasten the review process of psychedelic drugs.</p> <p>Other companies in the sector also reaped benefits.&nbsp;<strong>GH Research</strong>&nbsp;<a class="ticker-link" data-ticker="GHRS" data-exchange="NASDAQ" href="https://www.benzinga.com/quote/GHRS" target="_blank" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/GHRS">GHRS</a>)</a> shares rose by 17.23%.</p> <div class="bz-read-next-block"<br /> ...</div><p><a href=https://www.benzinga.com/markets/equities/26/04/51910727/enveric-biosciences-surges-over-90-other-psychedelic-stocks-soar-in-monday-pre-market-whats-goin?utm_source=benzinga_taxonomy&amp;utm_medium=rss_feed_free&amp;utm_content=taxonomy_rss&amp;utm_campaign=channel alt=Enveric BioSciences Surges Over 90%, Other Psychedelic Stocks Soar In Monday Pre-Market: What&#039;s Going On?>Full story available on Benzinga.com</a></p> ATAI CMPS DFTX Donald Trump ENVB GHRS Government mental health News Psychedelics Health Care Politics FDA Markets ATAI US00211V1061 CMPS ENVB GHRS DFTX News Government Psychedelics Health Care Politics FDA Markets Benzinga Mon, 20 Apr 2026 12:35:35 +0000 Namrata Sen 51910727 at https://www.benzinga.com https://www.benzinga.com/news/health-care/26/04/51905619/baby-food-recalled-after-jars-test-positive-for-rat-poison?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p>Baby food brand <strong>HiPP</strong> is recalling jars of infant food sold at SPAR supermarkets in Austria after samples tested positive for rat poison, the<strong> Associated Press</strong> <a href="https://apnews.com/article/rat-poison-baby-food-hipp-austria-f62aa2caa8f4239841dbe7a341b8bfcd">reported</a> Sunday, triggering a precautionary sweep across three Central European countries.</p> <h2 class="wp-block-heading">Tampering Detected Saturday</h2> <p>The contamination was detected in 190-gram jars of carrot and potato puree designed for infants five months and older. The first sample tested positive on Saturday. Vendors in Slovakia and the Czech Republic have since pulled all HiPP baby food jars from shelves.</p> <p>HiPP said the tampering was not a manufacturing failure. &#8220;The jars left our HiPP facility in perfect condition,&#8221; the company said in a statement Sunday, according to the AP. &#8220;The recall is related to a criminal act currently under investigation by the authorities.&#8221;</p> <h2 class="wp-block-heading">What To Look For</h2> <p>Burgenland Police ...</p><p><a href=https://www.benzinga.com/news/health-care/26/04/51905619/baby-food-recalled-after-jars-test-positive-for-rat-poison?utm_source=benzinga_taxonomy&amp;utm_medium=rss_feed_free&amp;utm_content=taxonomy_rss&amp;utm_campaign=channel alt=Baby Food Recalled After Jars Test Positive For Rat Poison>Full story available on Benzinga.com</a></p> News recall FDA Global News FDA Global Benzinga Mon, 20 Apr 2026 07:54:18 +0000 Tanya Rawat 51905619 at https://www.benzinga.com https://www.benzinga.com/news/fda/26/04/51855302/eli-lillys-new-oral-weight-loss-drug-clears-cardiovascular-bar?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p>On Thursday, <strong>Eli Lilly and Co. <a href="https://www.benzinga.com/quote/LLY" target="_blank" class="ticker-link" data-ticker="LLY" data-exchange="NYSE" rel="noopener">(NYSE:<a class="ticker" href="https://www.benzinga.com/quote/LLY">LLY</a>)</a></strong> reported positive topline results from its Phase 3 ACHIEVE-4 trial of its oral drug Foundayo (orforglipron) <a target="_blank" href="https://www.benzinga.com/topic/weight-loss" rel="noreferrer noopener">for weight loss</a>.</p> <p>The study showed that orforglipron met the primary goal of cardiovascular safety compared with insulin glargine in adults with type 2 diabetes and obesity or overweight at <a target="_blank" href="https://www.benzinga.com/markets/equities/26/04/51607074/why-is-eli-lilly-stock-gaining-today" rel="noreferrer noopener">elevated cardiovascular risk</a>.</p> <p>The study also indicated stronger reductions in blood sugar and body weight, positioning the therapy as a potential alternative to insulin-based treatment.</p> <h2 class="wp-block-heading">Foundayo Meets Cardiovascular Safety Goal</h2> <p>The ACHIEVE-4 trial, the <a href="https://www.benzinga.com/pressreleases/26/04/n51852082/achieve-4-the-longest-phase-3-study-of-lillys-foundayo-orforglipron-to-date-reaffirmed-its-cardiov" target="_blank" rel="noreferrer noopener">largest and longest study</a> of Foundayo in type 2 diabetes so far, enrolled more than 2,700 participants across 15 countries. </p> <p>The drug demonstrated a non-inferior risk of major adverse cardiovascular events (MACE-4), including cardiovascular death, heart attack, stroke, and hospitalization for unstable chest pain, <a href="https://www.benzinga.com/news/health-care/26/03/51430580/eli-lilly-to-phase-out-select-insulin-products-across-europe-by-2027" target="_blank" rel="noreferrer noopener">compared with insulin glargine</a>.</p> <p>The risk of these events was 16% lower with Foundayo, with a hazard ratio of 0.84, meeting predefined criteria for non-inferiority.</p> <div class="bz-read-next-block"<br /> ...</div><p><a href=https://www.benzinga.com/news/fda/26/04/51855302/eli-lillys-new-oral-weight-loss-drug-clears-cardiovascular-bar?utm_source=benzinga_taxonomy&amp;utm_medium=rss_feed_free&amp;utm_content=taxonomy_rss&amp;utm_campaign=channel alt=Eli Lilly&#039;s New Oral Weight Loss Drug Clears Cardiovascular Bar>Full story available on Benzinga.com</a></p> Biotech Large Cap LLY News Weight Loss Health Care FDA Top Stories General LLY US5324571083 News Biotech Large Cap Health Care FDA Top Stories General Benzinga Thu, 16 Apr 2026 12:39:07 +0000 Vandana Singh 51855302 at https://www.benzinga.com https://www.benzinga.com/news/health-care/26/04/51855015/fda-to-review-easing-grip-on-several-peptide-therapies-popular-among-influencers-and-fitness-gur?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p>On Wednesday, the <strong>Food and Drug Administration</strong> (FDA) said it plans to hold a meeting in July to review whether to loosen regulations on several unapproved peptide injections that have gained popularity among wellness influencers and celebrities.</p> <p>The FDA has scheduled meetings on July 23 and 24 for its Pharmacy Compounding Advisory Committee to evaluate seven peptide compounds, including BPC-157, for possible inclusion on the list of substances pharmacies can legally produce. </p> <h2 class="wp-block-heading"><strong>Political And Regulatory Context</strong></h2> <p>The development follows public statements from Health Secretary <strong>Robert F. Kennedy Jr.</strong>, who has supported broader access to peptide therapies. Kennedy oversees the Department of Health and Human Services, which includes the FDA.</p> <p>The review marks a shift from earlier FDA action in 2023, when the agency restricted nearly 20 peptides from ...</p><p><a href=https://www.benzinga.com/news/health-care/26/04/51855015/fda-to-review-easing-grip-on-several-peptide-therapies-popular-among-influencers-and-fitness-gur?utm_source=benzinga_taxonomy&amp;utm_medium=rss_feed_free&amp;utm_content=taxonomy_rss&amp;utm_campaign=channel alt=FDA To Review Easing Grip On Several Peptide Therapies Popular Among Influencers And Fitness Gurus In Potential Win For RFK Jr.>Full story available on Benzinga.com</a></p> Equities Government HIMS News Regulations Health Care FDA HIMS News Equities Government Regulations Health Care FDA Benzinga Thu, 16 Apr 2026 12:30:22 +0000 Tanya Rawat 51855015 at https://www.benzinga.com https://www.benzinga.com/news/health-care/26/04/51851887/why-is-hims-hers-stock-soaring-after-fdas-announcment?utm_source=benzinga_taxonomy&utm_medium=rss_feed_free&utm_content=taxonomy_rss&utm_campaign=channel <p><strong>Hims &amp; Hers Health, Inc.</strong> <a href="https://www.benzinga.com/quote/HIMS" target="_blank" class="ticker-link" data-ticker="HIMS" data-exchange="NASDAQ" rel="noopener">(NASDAQ:<a class="ticker" href="https://www.benzinga.com/quote/HIMS">HIMS</a>)</a> shares are trading higher during Thursday&#039;s premarket session after the company backed the FDA&#039;s plans to clarify the regulatory status of peptide therapies and signaled efforts to expand access.</p> <h2 class="wp-block-heading">Regulatory Shift</h2> <p>Health Secretary <strong>RFK Jr</strong>. indicated that the FDA will ease restrictions on peptide injections, marking a shift from earlier rules that had limited their use due to safety concerns and a lack of human testing, <a target="_blank" href="https://www.bloomberg.com/news/articles/2026-04-15/hims-jumps-as-rfk-jr-seeks-to-loosen-peptide-regulations" rel="noreferrer noopener">Bloomberg reported</a>.</p> <p>The FDA now plans to review select peptides in July and may remove them from the high-risk list in the interim, potentially opening up a significant new revenue stream for companies like Hims that rely on compounding pharmacies.</p> <h2 class="wp-block-heading">FDA Clarity On Peptide Therapies</h2> <p>The company <a target="_blank" href="https://news.hims.com/newsroom/applauding-move-towards-regulatory-clarity-on-peptide-therapy" rel="noreferrer noopener">said</a> the FDA&#039;s move could shift peptide treatments out of the gray market into regulated channels overseen by healthcare professionals.</p> <p>It added that it is actively exploring ways to expand access in alignment with FDA guidance, with a focus on consumer safety, transparency, and clinical standards.</p> <h2 class="wp-block-heading">Longevity Care Expansion</h2> <p>Hims &amp; Hers said its medical team believes certain ...</p><p><a href=https://www.benzinga.com/news/health-care/26/04/51851887/why-is-hims-hers-stock-soaring-after-fdas-announcment?utm_source=benzinga_taxonomy&amp;utm_medium=rss_feed_free&amp;utm_content=taxonomy_rss&amp;utm_campaign=channel alt=Why Is Hims &amp; Hers Stock Soaring After FDA&#039;s Announcment?>Full story available on Benzinga.com</a></p> benzai HIMS News why it's moving FDA Top Stories Movers HIMS News FDA Top Stories Movers Benzinga Thu, 16 Apr 2026 10:28:19 +0000 Akanksha Bakshi 51851887 at https://www.benzinga.com