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  • Study shows drug development and reimbursement timelines align across four major markets
    Researchers published a cross‑sectional analysis in JAMA Health Forum examining how long it takes for a drug to move from the start of clinical trials to receiving reimbursement approval. The anal…
    raps · 1mo agoNeutral↗ source
  • FDA panel backs compounding pharmacies to make two peptides, rejects third
    The U.S. Food and Drug Administration’s advisory committee met on Friday and issued recommendations on the manufacturing of certain peptide drugs by compounding pharmacies. Committee members voted…
    STAT · 1mo agoRegulatoryNeutral↗ source
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  • AstraZeneca says Wainua failure won’t alter M&A plans, stays on track for $80B 2030 goal
    AstraZeneca said during its Q2 earnings presentation that the late‑stage failure of the antisense therapy Wainua in ATTR‑cardiomyopathy does not derail its goal of reaching $80 billion in revenue b…
    BioSpace · 1mo agoDealNeutral↗ source
  • 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 · 1mo 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 · 1mo agoRegulatoryNeutral↗ source
  • Medical schools add hands-on nutrition programs while avoiding broader HHS priorities
    When students return to McGovern Medical School at UT Health Houston, they will take part in hands‑on nutrition experiences such as cooking demonstrations, tours of a holistic garden, and a culinar…
    STAT · 1mo agoNeutral↗ source
  • E‑bikes and e‑scooters driving surge in severe pediatric injuries, say pediatric surgeons
    J. Todd R. Lawrence, a pediatric orthopedic surgeon, and Madison A. Kesler, a research associate at Children’s Hospital of Philadelphia, note a rapid rise in serious injuries among children using e…
    STAT · 1mo agoNegative↗ source
  • Midwives urge role in combating medical misinformation as patients reject blood based on vaccine myths
    Midwife Mara Evans, based in North Carolina and faculty at Georgetown University’s Berkley School of Nursing, writes about her experience in a Nevada delivery room. She describes the careful handli…
    STAT · 1mo agoNeutral↗ 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 · 1mo agoNegative readoutNegative↗ source
  • 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 · 1mo agoDealPositive↗ source
  • Amgen seeks FDA hearing to keep rare kidney drug Tavneos amid safety concerns
    Amgen has asked the U.S. Food and Drug Administration for a hearing to argue against a proposed withdrawal of its rare‑disease drug Tavneos. The company submitted a data package containing real‑wo…
    BioSpace · 1mo agoRegulatoryNegative↗ source
  • Merck grants royalty-free licenses for experimental HIV prevention pill to generic makers in 129 low-income countries
    Merck announced voluntary licensing agreements that let generic manufacturers produce its experimental HIV prevention pill, known as alimatravir, in low- and middle-income markets. The deals cover…
    STAT · 1mo 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 · 1mo agoRegulatoryNeutral↗ source
  • Fatal gene-editing trial in China sparks ethics and oversight concerns
    A six-year-old girl in China died after receiving an experimental brain-directed CRISPR therapy, according to a report in Science. The tragedy has intensified calls for stronger ethical review and…
    STAT · 1mo agoRegulatoryNegative↗ source
  • FDA panel backs compounding pharmacies to produce four peptide drugs, amid insulin pen shortage and Merck HIV pill license
    An FDA advisory committee voted to allow compounding pharmacies to prepare four peptide-based medicines, a decision hailed by supporters of peptide therapeutics. The briefing also mentioned that M…
    STAT · 1mo agoRegulatoryPositive↗ source
  • Summit Therapeutics faces under a year of cash runway as FDA decision on ivonescimab looms
    Summit Therapeutics reported that its cash and short-term investments total just over $690 million, which the company says is insufficient to fund operations for a full year. The biotech’s lead ca…
    BioSpace · 1mo agoRegulatoryNeutral↗ source
  • Roche drops Carmot’s acmopatide after Phase 2 success, shifts focus to enicepatide for weight loss and diabetes
    Roche announced it will stop developing acmopatide, an investigational obesity treatment acquired from Carmot Therapeutics. Acmopatide had met its primary endpoint in a Phase 2 trial in type 1 dia…
    BioSpace · 1mo agoNeutral↗ source
  • U.S. drug shortages stem from weak regulation, not China competition, says expert
    In 2025 the United States faced 216 active drug shortages, limiting access to lifesaving medicines for patients. While the White House and national‑security officials have framed the problem as a…
    STAT · 1mo agoRegulatoryNegative↗ source
  • White House science blueprint pushes billions toward AI firms, away from university life-science research
    The White House Office of Science and Technology Policy released a report titled “Science: A New Golden Age.” The document outlines a new direction for U.S. federal science funding. The plan calls…
    STAT · 1mo agoRegulatoryNegative↗ source
  • Baxter recalls cefazolin injection after cardboard particles detected
    Baxter International announced a voluntary nationwide recall of lot LD175708 of its cefazolin in dextrose injection, a single‑dose 100 ml infusion bag. The recall was prompted by a report that car…
    fda recalls · 1mo agoCRLNegative↗ source
  • FDA issues early alert on Boston Scientific ENROUTE catheter tip separation risk
    The CDRH has issued an Early Alert warning about a potential high risk issue with Boston Scientific's ENROUTE Transcarotid Neuroprotection System and its Plus version. The problem involves possibl…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Sunny Pharmtech voluntarily recalls three lots of cyclophosphamide injection after steel particles found
    Sunny Pharmtech, Inc. announced a voluntary nationwide recall of three lots of cyclophosphamide for injection, USP, in 1‑gram and 2‑gram vials. The recall was triggered by the detection of steel pa…
    fda medwatch · 1mo agoCRLNeutral↗ source
  • FDA advisory panel recommends adding peptides BPC-157 and KPV to bulk compounding list
    An FDA advisory committee voted 8-6, with one abstention, to recommend that two experimental peptides – BPC-157 for ulcerative colitis and KPV for wound and inflammatory conditions – be placed on t…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA advisory panel adds six peptides to compounding bulk drug list, rejects one
    The FDA’s advisory committee concluded a two-day meeting on Friday, reviewing seven peptide drug substances for inclusion on the agency’s bulk-drug compounding list. Committee members voted to add…
    raps · 1mo agoRegulatoryNeutral↗ 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 · 1mo agoDealNeutral↗ source