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  • Biohaven signs up to $795 million deal with SK Biopharma to license Kv7 platform and epilepsy asset
    Biohaven announced a licensing agreement with South Korean SK Biopharma centered on its Kv7 ion channel platform and lead epilepsy candidate opakalim. The deal could deliver up to $795 million, in…
    BioSpace · 17d agoDealPositive↗ source
  • Akeso and Summit report ivonescimab meets primary endpoint in China Phase 3 biliary tract cancer trial
    Akeso Therapeutics and partner Summit Therapeutics announced that their bispecific antibody ivonescimab achieved the primary efficacy endpoint in a Phase 3 study conducted exclusively in China. Th…
    Endpoints · 17d agoPositive readoutPositive↗ source
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  • Faro AI secures $37M Series B to accelerate clinical trials with artificial intelligence
    Faro AI, a San Diego‑based startup, announced a $37 million Series B financing round aimed at expanding its artificial‑intelligence platform. The new funding will be directed toward developing too…
    Endpoints · 17d agoDealPositive↗ source
  • FDA grants three-month extension for Capricor's Duchenne muscular dystrophy cell therapy review
    The FDA has granted a three‑month extension to Capricor Therapeutics' review of its cell therapy for Duchenne muscular dystrophy after the original PDUFA date passed. The decision follows a content…
    BioSpace · 17d agoRegulatoryNeutral↗ source
  • Profit motive highlighted as key to advancing women’s health research and boosting economic productivity
    Experts say that turning to the profit motive could spur investment in under‑funded women’s health areas such as endometriosis, osteoporosis and autoimmune disorders. They note a long history of r…
    STAT · 17d agoNeutral↗ source
  • CDMO hiring struggles as demand for specialized talent outpaces supply
    Contract development and manufacturing organizations are finding it harder to fill positions, according to a search expert who tracks life-science talent. The surge in outsourcing has created a gap…
    BioSpace · 17d agoNeutral↗ source
  • Baxter voluntarily recalls one lot of anticoagulant sodium citrate solution over possible fiberglass particles
    Baxter International announced a voluntary recall of a single lot of its Anticoagulant Sodium Citrate Solution, USP, 250 mL, packaged in a VIAFLEX plastic container. The recall was triggered after…
    fda recalls · 17d agoCRLNegative↗ source
  • Kennedy spreads vaccine misinformation as measles deaths spark heated call with Pennsylvania governor
    After Pennsylvania health officials reported two deaths among unvaccinated individuals from measles, HHS Secretary Robert F. Kennedy Jr. phoned Governor Josh Shapiro to discuss federal assistance.…
    STAT · 16d agoNegative↗ source
  • Key data on lipoprotein(a)-targeting cardiovascular drugs expected soon
    A STAT+ newsletter highlights that several major pharmaceutical firms are developing drugs that lower lipoprotein(a), a particle linked to heart disease. The companies view Lp(a) reduction as a po…
    STAT · 16d agoNeutral↗ source
  • Insitro CEO Daphne Koller discusses using AI to accelerate clinical trials
    STAT+ AI Prognosis newsletter featured an interview with Insitro chief executive Daphne Koller about the role of artificial intelligence in drug discovery and how it could speed up clinical trials.…
    STAT · 16d agoNeutral↗ source
  • Two Unvaccinated Pennsylvania Residents Die from Measles, First US Measles Deaths in 2026
    The Pennsylvania Department of Health reported two measles-associated deaths in the state. Both individuals were unvaccinated, making these the first measles deaths in the United States for 2026 an…
    STAT · 16d agoNeutral↗ source
  • Spyre Therapeutics deprioritizes anti-TL1A rheumatoid arthritis candidate after modest Phase 2 results
    Spyre Therapeutics said on Tuesday it will shift resources away from its anti-TL1A antibody that was being developed for rheumatoid arthritis. The decision follows the Phase 2 study, which showed…
    Endpoints · 17d agoNegative readoutNegative↗ source
  • Oxford study finds Shingrix linked to lower risk of heart attacks, strokes and heart failure
    Researchers at Oxford University reported that receiving the newer shingles vaccine Shingrix was associated with a reduced risk of cardiovascular disease. The observation follows earlier work by t…
    STAT · 17d agoPositive readoutNeutral↗ source
  • Inside the Gulf biotech deal model, ahead of RGMBS 2026 in Riyadh
    Sovereign capital, guaranteed offtake, and localization mandates are reshaping how biotech deals get structured in the Gulf, ahead of the Riyadh Global Medical Biotechnology Summit (RGMBS) 2026, 14…
    BioSpace · 17d agoDealNeutral↗ source
  • Cellares defends its cell therapy platform after Bristol Myers ends partnership
    Cellares, a cell therapy manufacturing startup, responded to criticism from Bristol Myers Squibb after the drugmaker terminated their agreement. Bristol Myers withdrew, saying Cellares' commercial…
    Endpoints · 16d agoNegative↗ source
  • Calcium scans may guide statin decisions in a few borderline patients, studies find
    Two recent trials evaluated whether coronary artery calcium (CAC) scans, used together with the PREVENT risk calculator, can help decide on statin therapy. The studies compared the imaging results…
    STAT · 16d agoNeutral↗ source
  • FDA reportedly weighing two new deputy commissioner roles, one for health AI and one for drugs
    The Food and Drug Administration is said to be considering the creation of two additional deputy commissioner positions. The proposal is being reported by media outlets but has not been confirmed b…
    BioSpace · 17d agoRegulatoryNeutral↗ source
  • Revival Animal Health recalls two feline milk replacer products over low vitamin and mineral levels
    Revival Animal Health of Orange City, Iowa announced a voluntary recall of its Breeder’s Edge and Shelter’s Choice feline milk replacers. Testing revealed the products contain lower than expected…
    fda recalls · 16d agoCRLNegative↗ source
  • New York law adds recording safeguard to medical aid in dying, sparking ethical debate
    New York has enacted a law that permits terminally ill residents with six months or less to obtain medication for self-directed death. A distinctive feature of the legislation is that patients must…
    STAT · 17d agoRegulatoryNeutral↗ source
  • Many post-Dobbs abortion concerns have not materialized, says expert
    David N. Hackney, a professor of reproductive biology and division chief of maternal‑fetal medicine, reflects on the four years since the Supreme Court overturned Roe v. Wade. He notes that several…
    STAT · 17d agoNeutral↗ source
  • FDA expands Jazz's Ziihera to frontline HER2-positive gastroesophageal cancers, unlocking $1.5 billion market
    The U.S. Food and Drug Administration has broadened the approved use of Jazz Pharmaceuticals' cancer therapy Ziihera. The drug can now be given as an initial treatment for patients with HER2‑positi…
    BioPharma Dive · 17d agoApprovalPositive↗ source
  • FDA expands Jazz's Ziihera use to frontline gastric cancer
    FDA granted approval for Jazz Pharmaceuticals' bispecific antibody Ziihera as a frontline treatment for certain gastric cancer patients. This is the first time Ziihera will be marketed to newly di…
    Endpoints · 17d agoApprovalPositive↗ source
  • J&J’s Imaavy gains first-in-class label for warm autoimmune hemolytic anemia
    J&J announced that its monoclonal antibody Imaavy has received a label expansion in the United States. The expanded indication makes Imaavy the first therapy approved specifically for warm autoimm…
    Endpoints · 17d agoApprovalPositive↗ source
  • Eli Lilly launches oral obesity drug Foundayo in the UK
    Eli Lilly has introduced its oral weight‑loss pill Foundayo to the United Kingdom market, positioning the small‑molecule therapy as a price‑sensitive alternative to injectable options. The UK Medi…
    BioSpace · 18d agoRegulatoryPositive↗ source
  • Sword Health proposes acquisition of mental-health startup Headspace, linking two digital health unicorns
    Sword Health announced a proposal to acquire Headspace, a mental-health startup, according to a filing with Massachusetts state officials. The deal would combine two digital-health companies that…
    Endpoints · 17d agoDealNeutral↗ source