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  • Australia's TGA adopts 23 international scientific guidelines from EMA, ICH and FDA
    The Therapeutic Goods Administration (TGA) in Australia announced it has formally adopted 23 scientific guidelines. The guidelines come from the European Medicines Agency, the International Counci…
    raps · 2d agoRegulatoryNeutral↗ source
  • FDA schedules advisory committee meetings for rejected Replimune melanoma drug and Capricor DMD cell therapy
    The FDA announced that it will hold two advisory committee meetings this week to revisit investigational therapies that were previously turned down. One meeting will consider Capricor Therapeutics'…
    BioSpace · 2d agoRegulatoryNeutral↗ source
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  • ‘This could be a large market’: Novo Holdings-backed Claris secures $118M for corneal disease drug
    A new biotech has come into view with a $118 million series B and a vision for making the front of the eye front-of-mind.
    Fierce Biotech · 2d agoNeutral↗ source
  • MapLight’s schizophrenia drug dampens once-daily hopes despite Phase 2 win
    MapLight Therapeutics’ stock {$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 · 2d 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 · 2d 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 · 2d 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 · 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
  • 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
  • Apnimed aspires for up to $160M IPO as sleep apnea pill launch nears
    Apnimed has detailed its plans for an initial public offering, with the biotech intending to raise as much as $160 million to fund the launch of its sleep apnea pill.
    Fierce Biotech · 2d agoNeutral↗ source
  • MapLight shares sink on mixed phase 2 schizophrenia readout
    MapLight Therapeutics’ stock plummeted more than 60% this morning after the neuro outfit dropped mixed results for a phase 2 trial of its experimental schizophrenia treatment.
    Fierce Biotech · 2d agoNeutral↗ source
  • Legend Biotech CEO abruptly steps down without permanent replacement
    In a sudden leadership shift, Legend Biotech announced that its CEO, Ying Huang, Ph.D., resigned on Friday, with no permanent replacement yet named.
    Fierce Biotech · 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
  • Amgen sheds around 40 staffers amid continuing struggles
    Amgen has laid off around 40 employees as part of “organizational changes” meant to better align operations with the company’s strategic objectives, Fierce has learned.
    Fierce Biotech · 5d ago↗ 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
  • Sanofi’s $1.4B Kymab bet falters again as atopic dermatitis trials scrapped
    Sanofi had hoped the acquisition of Kymab would fill a major hole that will be left as autoimmune juggernaut Dupixent heads toward a patent cliff. Now, another therapy has failed to meet expectations.
    BioSpace · 5d ago↗ source
  • Scribe reels in nearly $129M in rare early-stage IPO for a gene editing biotech
    Jennifer Doudna–founded Scribe Therapeutics intends to use the proceeds from the public offering—the first for a gene editing outfit in over two years—to support development of its epigenetic silen…
    BioSpace · 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
  • Amgen deploys patients to defend troubled Tavneos in FDA hearing request
    Facing pressure around the world to withdraw the rare kidney disease drug Tavneos, Amgen has launched a robust defense with real-world evidence to support the product’s benefit-risk profile.
    BioSpace · 5d ago↗ source