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3,109 stories matching this filter · ← front page

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  • BeOne secures FDA approval for lymphoma therapy
    BeOne received FDA approval for its lymphoma therapy, a notable achievement in a crowded therapeutic area. The agency’s review concluded that the treatment meets safety and efficacy standards, pla…
    STAT · 3mo agoApprovalPositive↗ source
  • Regenxbio reports key gene therapy results, moves toward FDA accelerated clearance for Duchenne
    Regenxbio said its experimental gene therapy RGX-202 met the primary endpoint in a pivotal Duchenne muscular dystrophy trial, positioning the company to file for accelerated FDA clearance. In the…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ source
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  • Regenxbio reports successful Duchenne gene therapy trial, clearing path to FDA filing
    Regenxbio announced that its experimental gene therapy for Duchenne muscular dystrophy met its primary endpoints in a recent clinical trial, producing sufficient levels of a truncated muscle protei…
    STAT · 3mo agoPositive readoutPositive↗ source
  • Supreme Court blocks restrictions, keeps mifepristone available through pharmacies and mail
    Supreme Court on Thursday issued an order that maintains women's ability to obtain the abortion medication mifepristone without requiring an in-person doctor visit. The decision overturns a lower-…
    STAT · 3mo agoRegulatoryPositive↗ source
  • Create Medicines secures $122M Series B to advance in vivo CAR-T therapies
    Create Medicines, a Cambridge biotech, announced a $122 million Series B financing to expand its in vivo CAR-T cell therapy platform targeting cancer and autoimmune diseases. The round was co-led…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Biogen advances tau-targeting Alzheimer drug to Phase 3 despite mixed Phase 2 data
    Biogen reported results from a Phase 2 trial of its tau-targeting Alzheimer’s candidate diranersen (BIIB080). The study measured tau levels in cerebrospinal fluid and brain tissue of patients with…
    STAT · 3mo agoPositive readoutPositive↗ source
  • BeOne Medicines receives accelerated FDA approval for sonrotoclax in mantle cell lymphoma
    BeOne Medicines announced that the U.S. Food and Drug Administration granted accelerated approval to its BCL2 inhibitor sonrotoclax for treatment of mantle cell lymphoma. The approval is based on…
    Endpoints · 3mo agoApprovalPositive↗ source
  • FDA commissioner Marty Makary exits, acting head Kyle Diamantas named as podcast discusses impact and Senate health race
    The Readout Loud podcast episode focused on health politics, featuring a discussion of FDA commissioner Marty Makary's departure. Hosts examined why Makary is leaving, which of his policies might…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Encoded Therapeutics gene therapy cuts seizures 76% in Dravet syndrome children
    Encoded Therapeutics presented data at the ASGCT26 meeting showing its gene therapy achieved a 76% reduction in seizures among children with Dravet syndrome. The result was observed in three patie…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Degron Therapeutics raises $40M in Series A extension, total $95M, as Cabaletta releases early CAR‑T data
    Degron Therapeutics, a US‑China biotech focused on molecular‑glue degrader technology, announced an additional $40 million in Series A extension funding, bringing its total capital raised to $95 mi…
    Endpoints · 3mo agoDealNeutral↗ source
  • Biogen reports mixed results in mid‑stage trial of tau‑targeting Alzheimer’s therapy
    Biogen disclosed data from a Phase 2 study of its experimental Alzheimer’s drug that targets the tau protein. The trial showed a combination of positive and negative signals, with some measures ind…
    STAT · 3mo agoNegative readoutNeutral↗ source
  • Biogen's anti-tau Alzheimer drug BIIB080 fails primary endpoint in Phase 2, but shows slower decline
    Biogen reported results of its Phase 2 trial of BIIB080, a tau-targeting therapy for Alzheimer’s disease. The study’s primary endpoint was not met, meaning the drug did not achieve the pre-specifi…
    Endpoints · 3mo agoNegative readoutNeutral↗ source
  • Regenxbio reports positive Duchenne gene therapy trial results, targets FDA approval by 2027
    Regenxbio announced that its gene therapy for Duchenne muscular dystrophy achieved the required endpoints in a pivotal clinical trial. The data met the study's predefined criteria, which the compa…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • CREATE Medicines raises $122 million to advance CAR-T candidates into human trials
    CREATE Medicines, formerly Myeloid Therapeutics, announced a $122 million financing round. The funding came from Newpath Partners, ARCH Venture Partners, Hatteras Venture Partners and other invest…
    STAT · 3mo agoDealPositive↗ source
  • Acting FDA Commissioner Kyle Diamantas Seen as Drama-Free Stabilizer for Biotech
    Kyle Diamantas has been named the acting commissioner of the Food and Drug Administration, stepping into the role after Marty Makary’s resignation. He previously led the FDA’s food safety division,…
    STAT · 3mo agoRegulatoryPositive↗ source
  • FDA searches for new commissioner as Marty Makary departs, Trump administration outlines priorities
    Marty Makary is leaving his role at the FDA, as reported in STAT’s D.C. Diagnosis newsletter. The Trump administration has released a lengthy wish list for the next FDA commissioner, indicating th…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • MacroGenics sells manufacturing operations to Bora for $122.5M; West Pharma reports cybersecurity breach
    MacroGenics announced it is selling its clinical and commercial drug substance manufacturing portfolio to CDMO Bora. The deal includes an upfront payment of $122.5 million. The transaction transfe…
    Endpoints · 3mo agoDealNeutral↗ source
  • STAT launches investigative series on alcohol epidemic killing 178,000 Americans annually
    STAT has begun a new investigative series that examines the United States’ ongoing alcohol crisis, which the outlet says results in roughly 178,000 deaths each year. The reporting team traveled na…
    STAT · 3mo agoNegative↗ source
  • STAT+: CDC plans to transfer monkeys to nonprofit’s sanctuary as it seeks to reduce animal testing
    The CDC intends to transfer more than 160 macaques to Born Free USA, a nonprofit that runs a large primate sanctuary in Texas, as the agency seeks to phase out…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Biogen pushing tau drug forward despite Alzheimer’s study failure
    One of the company’s more closely watched research assets, BIIB080 is now heading to late-stage testing based on “the strength of the biomarker and efficacy data” seen in a Phase 2 trial.
    BioPharma Dive · 3mo agoRegulatoryNeutral↗ source
  • Major digital health firms stay out of Medicare's chronic care ACCESS pilot
    The latest STAT Health Tech newsletter reports that the biggest players in digital health are not participating in Medicare's ACCESS pilot, a program designed to test chronic-care solutions for Med…
    STAT · 3mo agoNeutral↗ source
  • Alcohol treatment sees growing shift toward alternatives beyond Alcoholics Anonymous
    The article highlights a growing movement away from traditional Alcoholics Anonymous programs toward newer, more flexible approaches for treating alcohol use disorder. It notes that many patients a…
    STAT · 3mo agoNeutral↗ source
  • In vivo CAR-T therapies dominate talks at ASGCT 2026 conference
    The reporter is on the ground in Boston covering the American Society of Gene & Cell Therapy's annual meeting. Sessions across the conference are highlighting in vivo CAR-T approaches, showing tha…
    Endpoints · 3mo agoNeutral↗ source
  • Pharma firms must complete extensive paperwork and undergo monitoring to qualify for a 20% tariff reduction
    The Department of Commerce announced that pharmaceutical manufacturers must complete a detailed application to qualify for a reduced 20% tariff rate. The requirement follows an executive order sig…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Three years of falling overdose deaths spark cautious optimism amid lingering concerns
    Over the past three years, the United States has seen a steady decline in overdose deaths, a trend that has generated cautious optimism among public‑health observers. While the numbers are encourag…
    STAT · 3mo agoPositive↗ source