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  • FDA reminds investors about the risks of advisory panels
    Two days, two similar briefing documents and two companies with diving share prices. The FDA this week laid out its concerns with clinical data from both Capricor Therapeutics and
    Endpoints · 14h agoRegulatoryNeutral↗ source
  • FDA offers updated guidance for generics of weight loss blockbusters
    The FDA revised its draft guidance for generic companies looking to develop copycats of some of the world's best-selling weight loss drugs, including Eli Lilly's Zepbound and Novo Nordisk's Ozempic…
    Endpoints · 15h agoRegulatoryNeutral↗ source
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  • FDA staff say Replimune's melanoma trial failed to prove RP1 works
    FDA staff threw cold water on Replimune’s advanced melanoma drug ahead of a critical meeting with agency advisors, writing that the pivotal study design failed to prove its drug actually works. The…
    Endpoints · 18h agoRegulatoryNeutral↗ source
  • The future of gray-market peptides
    Two days’ worth of debate among FDA advisory committee members and agency staff over whether compounding pharmacies should be able to make seven different peptides left me with some big ...
    Endpoints · 19h agoRegulatoryNeutral↗ source
  • J&J proposes $5.5B talc settlement
    After more than a decade and three failed bankruptcy attempts, an end to Johnson & Johnson’s talc saga may finally be in sight. The company has proposed a $5.5 billion settlement ...
    Endpoints · 14h agoNeutral↗ source
  • Oak Hill Bio merges with RA Capital SPAC; InnoCare's TYK2 drug hits in Phase 3
    💵 Oak Hill Bio’s SPAC merger: The Angelman syndrome biotech will merge with RA Capital’s blank-check company, called Research Alliance Corporation III, and get about ...
    Endpoints · 18h agoNeutral↗ source
  • Alnylam's stock is down 30% despite a booming biotech market. Here's why
    Alnylam is one of biopharma’s biggest mysteries so far in 2026. The broader market is seeing a resurgence after years of a bearish environment. M&A is up, IPOs are back with record-breaking force a…
    Endpoints · 19h agoNeutral↗ source
  • Mirae raises $5.4M to turn patient texts into data for doctors
    As people increasingly turn to AI chatbots for health questions, one startup wants patients to talk to its chatbot about their symptoms, so their doctors can make better treatment decisions. Mirae,…
    Endpoints · 20h agoNeutral↗ source
  • Claris collects $118M to take eye drop into pivotal testing next year
    Claris Bio has a fresh CEO, new board chair and $118 million for two pivotal trials to see if its eye drop can succeed in a blinding disease with no pharmaceutical treatment options. It's a ...
    Endpoints · 21h agoNeutral↗ source
  • Updated: GSK reveals three-year blueprint to cut costs and propel R&D
    Just a little over six months into his tenure as CEO at GSK, Luke Miels is making his mark. The drugmaker on Tuesday outlined plans for a three-year cost-cutting initiative, the launch of at least ...
    Endpoints · 21h agoNeutral↗ source
  • Updated: Altimmune’s GLP-1-based shot cuts drinking in patients with alcoholism
    Altimmune said Tuesday that its GLP-1/glucagon agonist reduced drinking in people with moderate-to-severe alcohol use disorder in a mid-stage study. Patients in the Phase 2 RECLAIM trial took a wee…
    Endpoints · 22h agoNeutral↗ 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 thyro…
    Endpoints · 1d agoApprovalPositive↗ 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 · 1d agoDealNeutral↗ source
  • Argenx to pick up autoimmune biotech Forte Biosciences for $2.2B
    Argenx will spend $2.2 billion to buy Forte Biosciences and its anti-CD122 monoclonal antibody that’s under investigation for autoimmune diseases. The Belgian-Dutch pharma said Monday it will pay $…
    Endpoints · 1d agoDealNeutral↗ source
  • Virginia federal judge says FDA should reconsider mifepristone restrictions
    At a time when the federal government is evaluating restrictions on medication abortion, a federal judge determined that the last administration imposed too many. A Virginia federal judge ordered t…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • Capricor's DMD therapy lacks efficacy, FDA says ahead of adcomm
    The FDA is again questioning the efficacy of Capricor's cell therapy for Duchenne muscular dystrophy, this time ahead of an advisory committee meeting on Wednesday. The agency's review team said it…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • Six wellness peptides win backing from FDA advisory committee
    After two days of meetings, an FDA advisory committee last week voted to lift restrictions on six popular health and wellness peptides, setting aside FDA staff concerns about a lack of safety and e…
    Endpoints · 1d agoRegulatoryNeutral↗ source
  • MapLight’s schizophrenia drug dampens once-daily hopes despite Phase 2 win
    MapLight Therapeutics’ stock {$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 · 1d agoNeutral↗ 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 · 1d agoNeutral↗ 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 in a
    Endpoints · 1d agoNeutral↗ 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 fro…
    Endpoints · 1d 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 · 1d agoNeutral↗ 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 · 1d 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 · 1d 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 · 3d agoEarningsNeutral↗ source