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  • 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 · 3d agoRegulatoryNeutral↗ source
  • Sanofi scraps most atopic dermatitis trials after amlitelimab fails to outperform standard care
    Sanofi announced it is halting all but one ongoing trial for amlitelimab, an OX40‑ligand antibody acquired through its $1.4 billion purchase of Kymab. The decision follows the Phase 3 COAST‑1 stud…
    BioSpace · 5d agoNegative readoutNegative↗ source
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  • Scribe Therapeutics raises $129 million in rare early-stage IPO to fund epigenetic heart disease therapy
    Scribe Therapeutics, founded by Jennifer Doudna, completed an IPO raising nearly $129 million, selling 8.58 million shares at $15 each. It is the first gene‑editing company to go public in more tha…
    BioSpace · 5d agoDealPositive↗ 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
  • Sanofi stops development of eczema drug amlitelimab after mixed trial results
    Sanofi announced on Friday that it is halting further development of amlitelimab for atopic dermatitis, a drug it had once promoted as a potential successor to its blockbuster Dupixent. The compan…
    BioPharma Dive · 5d agoNegative↗ 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 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
  • 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
  • Novo escalates legal fight with Lilly; J&J reinforces ‘dominance’ in multiple myeloma
    Novo is seeking an injunction that would halt allegedly “misleading” obesity drug ads. Elsewhere, the FDA began reviewing a highly anticipated medicine and a veteran investor landed at an AI startup.
    BioPharma Dive · 5d ago↗ source
  • Lilly’s $3.8B psychedelics bet won’t open the M&A floodgates
    Eli Lilly’s $3.8 billion play for AtaiBeckley has fueled speculation that Big Pharma is ready to embrace psychedelics. But while the acquisition does validate the drug class, analysts say it is unl…
    BioSpace · 5d ago↗ source
  • Summit has less than a year of cash runway left as PD-1/VEGF verdict nears
    Summit’s star asset is the PD-1/VEGF bispecific ivonescimab, which this week produced promising survival data from a late-stage global trial in non-small cell lung cancer. The FDA review is ongoing…
    BioSpace · 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
  • Roche cans one Carmot obesity asset as another shows best-in-class potential
    Acmopatide met the main goal of a Phase 2 study in type 1 diabetes, but Roche is axing the investigational drug to prioritize enicepatide for weight loss, type 2 diabetes and cardiovascular outcome…
    BioSpace · 6d 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 · 6d 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 · 6d 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 · 6d 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 · 6d 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 · 6d ago↗ source
  • Scribe secures $129M in a rare gene editing IPO
    The startup is the first gene editing company to price an IPO in more than two years, though it banked far less than most other biotechs that have gone public in 2026.
    BioPharma Dive · 6d ago↗ source
  • FDA panel endorses broader use of certain peptides
    In a victory for Robert F. Kennedy Jr.’s “MAHA” agenda, panelists narrowly recommended broader use of six of the seven peptides up for consideration despite a lack of substantive evidence supportin…
    BioPharma Dive · 6d ago↗ source
  • This Week at FDA: Diamantas touts onshoring efforts, grants for DHTs, and more
    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This we…
    raps · 6d ago↗ source
  • FDA advisory committee backs two more peptides, rejects one for compounding list
    By the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration (FDA) voted in favor of adding six of the seven peptides it was tasked…
    raps · 6d ago↗ source