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  • 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 fro…
    Endpoints · 2d agoNeutral↗ 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 · 2d agoNeutral↗ source
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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 · 2d agoNeutral↗ 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 · 2d agoNeutral↗ source
  • Upcoming Q2 earnings from Moderna, AstraZeneca, GSK and others highlighted in weekly pharma preview
    The Endpoints Weekly newsletter signals a busy earnings week for major pharmaceutical companies, with Q2 results slated from Moderna, AstraZeneca, GSK, Bristol Myers Squibb and several others. It…
    Endpoints · 4d agoEarningsNeutral↗ source
  • Amgen submits new analysis to FDA to defend continued availability of Tavneos
    Amgen has provided the FDA with a fresh analysis concerning its rare-disease therapy Tavneos, aiming to address the agency’s concerns. The company says the independent reevaluation supports the dr…
    Endpoints · 5d agoRegulatoryNeutral↗ source
  • FDA panel backs compounding of epitalon, rejects emideltide in narrow vote
    The FDA advisory committee voted to allow compounding pharmacies to produce the peptide epitalon, while narrowly voting against allowing the production of emideltide. The decision follows the pane…
    STAT · 5d agoRegulatoryNeutral↗ source
  • U.S. measles cases in 2026 already exceed total from record-breaking 2025 year
    The CDC reports 2,318 measles cases in the United States so far in 2026, surpassing the 2,289 cases recorded for the entire year of 2025. The increase makes 2026 the worst measles year since 1991,…
    STAT · 5d agoNeutral↗ source
  • Rigel Pharmaceuticals appoints Alison Hannah as executive vice president and chief medical officer
    Rigel Pharmaceuticals announced that it has hired Alison Hannah to serve as executive vice president and chief medical officer. Hannah joins Rigel after holding the same senior medical leadership…
    STAT · 5d agoPositive↗ source
  • Former FDA food safety chief warns nutrition push may overlook cyclospora outbreak risks
    Susan Mayne, who led the FDA’s Center for Food Safety and Applied Nutrition from 2015 to 2023, argues that nutrition and food safety cannot be treated separately. She says the two are linked and bo…
    STAT · 5d agoNeutral↗ source
  • Ipsen’s Bylvay fails key trial in children with rare liver disease
    Ipsen disclosed that Bylvay failed a Phase 3 study for biliary atresia, a serious liver disease that leads the bile ducts to become blocked in babies. Babies with the disease can get a Kasai proced…
    Endpoints · 5d ago↗ source
  • Biogen’s Alzheimer’s data spur excitement, confusion about tau-targeting drugs
    LONDON — One of the most anticipated Alzheimer’s studies in the past few years has created both enthusiasm and confusion, according to conversations Endpoints News recently had with about 20 scient…
    Endpoints · 5d ago↗ source
  • Novo asks court to block Lilly ads; Merck strikes HIV PrEP deal
    Plus news about Abbvie and Genmab, Johnson & Johnson and Mannkind. Novo urges court to block Lilly’s GLP-1 ads: Novo Nordisk asked a New Jersey federal court on Friday to temporarily block what it…
    Endpoints · 5d ago↗ source
  • STAT+: Fatal gene-editing trial in China raises ethics and oversight questions
    Sanofi insulin pen in short supply, a win for peptide compounds, and more biotech news from The Readout
    STAT · 5d ago↗ source
  • STAT+: Pharmalittle: We’re reading about an FDA panel and peptides, a Merck license for an HIV pill, and more
    In a win for peptide proponents, an FDA advisory panel recommended compounding pharmacies be allowed to make four of the drugs
    STAT · 5d ago↗ source
  • CHMP recommends Minoryx’s ALD drug, rejects Zevra’s Meplyffa
    Minoryx Therapeutics finally scored backing from EU regulators for its neurological drug that’s faced multiple hurdles. Meanwhile, Zevra’s rare disease drug got a setback in Europe almost two years…
    Endpoints · 5d ago↗ source
  • A new, separate outbreak of the diarrhea-causing parasite
    A win for peptide proponents, autism advisory committees clash, and more health news from Morning Rounds
    STAT · 5d ago↗ source
  • Michael Ehlers joins Formation Bio to lead R&D; Black Diamond co-founder dies at 67
    Michael Ehlers left his CEO role at Ascidian Therapeutics, the exon editing company he co-founded, to run R&D at the AI biotech Formation Bio. It’s not often that biotech executives leave ...
    Endpoints · 5d ago↗ source
  • STAT+: Merck strikes voluntary licensing deals in poor countries for an experimental HIV prevention pill
    Merck is striking licensing deals for its experimental HIV prevention pill in hope of getting wide-scale production started quickly.
    STAT · 5d ago↗ source
  • Sanofi nixes Kymab-originated OX40L antibody in atopic dermatitis
    Sanofi has decided to stop working on a drug for eczema it had hoped would be a successor to its immunological megablockbuster Dupixent. The French pharma said that it won’t seek ...
    Endpoints · 5d ago↗ source
  • Opinion: I may be one of the last middle-class medical students who could afford to become a doctor
    A federal loan program made it possible for Gauri Gurumurthy to pursue medicine. Now that program is changing.
    STAT · 5d ago↗ source
  • Opinion: The U.S. pharmaceutical supply chain problem is not about China
    The national security framing of the discussion around pharmaceutical supply chain vulnerabilities is a distraction, writes Pooja Yerramilli.
    STAT · 5d ago↗ source
  • Senate advances MAHA-friendly bill for food warning labels and junk food ad bans
    Unexpected alliances among Republicans and Democrats were on display over a bill meant to rein in ultra-processed foods.
    STAT · 5d ago↗ source
  • STAT+: White House offers its science blueprint: More AI, less life sciences
    The Trump administration released its blueprint for U.S. science, calling for shifting hundreds of billions of research dollars from universities to industry.
    STAT · 5d ago↗ source
  • Early Alert: Percutaneous Catheter Issue from Boston Scientific
    ENROUTE Transcarotid Neuroprotection Systems may have arterial sheath tip separation or partial tip separation during use
    fda medwatch · 5d ago↗ source