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  • Virginia federal judge says FDA should reconsider mifepristone restrictions
    At a time when the federal government is evaluating restrictions on medication abortion, a federal judge determined that the last administration imposed too many. A Virginia federal judge ordered…
    Endpoints · 2h ago↗ source
  • The patent cliff is looming and CDMOs need to be prepared, Fujifilm CEO says
    As drugmakers prepare for the looming biopharma patent cliff, 2026 has so far been a year for dealmaking. Now, contract manufacturers need to broaden their services to keep up, Fujifilm Biotechnolo…
    Endpoints · 2h ago↗ source
  • STAT+: Pharma’s drug spending deflection
    Job lock, surging prescription drug costs, No Surprises Act update, and more from STAT's Health Care Inc.
    STAT
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· 2h ago
↗ source
  • Capricor's DMD therapy lacks efficacy, FDA says ahead of adcomm
    The FDA is again questioning the efficacy of Capricor's cell therapy for Duchenne muscular dystrophy, this time ahead of an advisory committee meeting on Wednesday. The agency's review team said…
    Endpoints · 3h ago↗ source
  • Six wellness peptides win backing from FDA advisory committee
    After two days of meetings, an FDA advisory committee last week voted to lift restrictions on six popular health and wellness peptides, setting aside FDA staff concerns about a lack of safety and e…
    Endpoints · 3h ago↗ source
  • MapLight dives despite positive data for schizophrenia drug
    <figure><div><img src="https://imgproxy.divecdn.com/hE3SUiWFPTXu78esitpkGlFwKNqX19ie92vbcO82d5g/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xNDQ5MjI0OTcwXzIua…
    BioPharma Dive · 4h ago↗ source
  • Argenx to acquire Forte in $2.2B deal for ‘differentiated’ immune drug
    <figure><div><img src="https://imgproxy.divecdn.com/nnTWCzHBd9_O2uNBVPF6xmxcO0M-nRFDpca5z-2Xchs/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xNDMwNzQzODA0LmpwZ…
    BioPharma Dive · 5h ago↗ source
  • Yarrow to begin trading as it targets Graves; FDA approves Otsuka's ADHD pill
    Plus news about Outlook Therapeutics, Gossamer Bio, Apnimed and Entera Bio. 📈 Yarrow closes merger to go public: Yarrow Bioscience is developing an anti-TSHR antibody for Graves’ disease and thy…
    Endpoints · 5h ago↗ source
  • MapLight’s schizophrenia drug dampens once-daily hopes despite Phase 2 win
    MapLight Therapeutics’ stock {$MPLT} plummeted more than 60% on Monday after a once-daily regimen of its schizophrenia drug missed the primary endpoint in a mid-stage trial, despite the study’s ove…
    Endpoints · 5h ago↗ source
  • MapLight’s schizophrenia drug disappoints once-daily hopes despite Phase 2 win
    MapLight Therapeutics’ stock {$MPLT} plummeted more than 60% on Monday after a once-daily regimen of its schizophrenia drug missed the primary endpoint in a mid-stage trial, despite the study’s ove…
    Endpoints · 5h ago↗ source
  • FDA scientists question Capricor data; Legend CEO steps down
    <figure><div><img src="https://imgproxy.divecdn.com/idsdMAHsPbXObDUtQW2qRG7uveBUVv6HCTn9NTtlDOI/g:nowe:0:0/c:1207:682/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0x…
    BioPharma Dive · 5h ago↗ source
  • Sarepta, in search of a turnaround, taps ex-AbbVie exec Severino as CEO
    <figure><div><img src="https://imgproxy.divecdn.com/WuH_AaE1tfJ0k6kCbc3Pl9229iGeCCh2cRL_fgDY5lg/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9TYXJlcHRhX1Bob3RvXzEuSlBH.webp"/><…
    BioPharma Dive · 6h ago↗ source
  • RA Capital launches rare disease company Oak Hill Bio onto Nasdaq via SPAC
    Rare disease biotech Oak Hill is headed to the Nasdaq through a SPAC merger with RA Capital-sponsored Research Alliance Corporation III (RACC) to fund a rare genetic disease candidate.
    Fierce Biotech · 7h ago↗ source
  • STAT+: Sarepta names Michael Severino, former Tessera CEO, as new chief executive
    The beleaguered Sarepta Therapeutics named Michael Severino, who previously led Tessera Therapeutics, as its new CEO.
    STAT · 7h ago↗ source
  • Legend CEO Ying Huang resigns; Carvykti chief named interim leader
    Legend Biotech, the developer of the blockbuster cancer therapy Carvykti, is in the market for a new CEO. Ying Huang stepped down Friday after serving as CEO since November 2020, Legend announced…
    Endpoints · 7h ago↗ source
  • STAT+: Pharmalittle: We’re reading about a U.S. peptide panel’s votes, Amgen scuffling with the FDA, and more
    An FDA panel recommended that compounding pharmacies be allowed to make two more peptides, a step toward RFK Jr.'s goal to make them more available
    STAT · 7h ago↗ source
  • STAT+: Ahead of hearing, FDA questions the efficacy of Capricor’s Duchenne drug
    Ahead of a hearing, the FDA raised questions about the benefits of a Duchenne treatment from Capricor Therapeutics, another twist for the rare disease drug.
    STAT · 7h ago↗ source
  • Sarepta turns to Michael Severino as CEO, looking to move past recent turmoil
    Sarepta Therapeutics has found its new CEO as it seeks to recover from a calamitous past year. Michael Severino will replace the company’s longtime leader Doug Ingram on Tuesday. Severino joins f…
    Endpoints · 8h ago↗ source
  • A trend that isn’t fading, ultra-processed baby foods
    An FDA advisory panel serves some peptide wins, a measles record, and more health news from Morning Rounds
    STAT · 8h ago↗ source
  • STAT+: RA Capital backs upstart rival to Ultragenyx and Ionis in rare brain disease
    Oak Hill Bio, a new company backed by RA Capital and other investors, will take on Ultragenyx and Ionis in developing an Angelman syndrome medicine.
    STAT · 8h ago↗ source
  • [Podcast] From Protocol to Patient: Inside Clinical Supply with Almac Clinical Services
    <p>This podcast explores how clinical trial supplies move from early planning to global delivery, ensuring investigational medicines reach patients safely and on time.</p>
    BioPharma Dive · 8h ago↗ source
  • [Podcast] (Season 2) The Progress Profile: Alzheimer’s Research in Focus
    <p>This podcast explores how leading Alzheimer’s experts are working to bridge the gap between clinical trial design and frontline care.</p>
    BioPharma Dive · 8h ago↗ source
  • AstraZeneca looks to AI to ease risk in late-stage trials, speed up filings
    AstraZeneca’s use of AI in drug design and development has not yet yielded any clinical-stage candidates, CEO Pascal Soriot said Monday, but he added it could be useful in boosting the success of l…
    Endpoints · 9h ago↗ source
  • Updated: AstraZeneca foresees blockbuster sales for Claudin 18.2 ADC, but Ultomiris flops in rare disease
    AstraZeneca said Monday that a key late-stage trial of its Claudin 18.2-targeting ADC in stomach cancer had succeeded, albeit with a caveat — but another Phase 3 trial of Ultomiris yielded subpar r…
    Endpoints · 9h ago↗ source
  • Schrödinger debuts AI agent Bunsen to use its physics software
    Three years ago, Schrödinger CEO Ramy Farid ruffled some feathers by pushing back on the AI fever of the moment. He said AI hype was at "dangerous" and "insane" levels, warning there ...
    Endpoints · 9h ago↗ source