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582 stories matching this filter · ← front page

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  • Roche KRAS drug succeeds in head-to-head lung cancer study
    The Phase 3 trial compared Roche’s divarasib with treatments sold by Amgen and Bristol Myers in patients with non-small cell lung cancer.
    BioPharma Dive · 1mo ago↗ source
  • Kao USA Voluntarily Recalls Some Lots of Oribe Serene Scalp Densifying Shampoo
    CINCINNATI--(BUSINESS WIRE)--Kao USA Inc. (“Kao USA”) today issued a voluntary recall of select lots of its Oribe Serene Scalp Densifying Shampoo (8.5 oz and 33.8 oz) in the U.S. and Canada due to…
    fda recalls · 1mo ago↗ source
  • Eunha Fisheries Co., LTD. Issues Allergy Alert on Undeclared Wheat, Soy, and Sesame in Certain Frozen Olive Flounder Sashimi Products
    July 01, 2026 EUNHA FISHERIES CO., LTD., Busan, Republic of Korea, is recalling certain Sliced Korean Halibut and Flounder Sashimi products because the accompanying soy sauce and vinegar red pepper…
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fda medwatch38
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Psychiatry & CNS712
Ophthalmology421
Endocrinology & Metabolism382
Pain376
Infectious Disease356
fda recalls · 1mo ago↗ source
  • BridgeBio gets funding for drug launch; United buys into cell therapy
    Elsewhere, Otsuka’s kidney drug hit the goal of a confirmatory trial and Vertex’s CRISPR sickle cell drug secured expanded approval.
    BioPharma Dive · 1mo ago↗ source
  • Ipsen to buy Swiss biotech Memo Therapeutics in potential $800M deal
    The purchase hands Ipsen an experimental medicine in late-stage testing for a virus that often affects kidney transplant patients.
    BioPharma Dive · 1mo ago↗ source
  • 5 FDA decisions to watch in the third quarter of 2026
    A group of coming decisions could provide important insights into how flexible the agency is willing to be under new leadership.
    BioPharma Dive · 1mo ago↗ source
  • Abivax shares surge as worries subside over immune drug’s cancer risk
    According to Abivax, fresh data suggest malignancy rates in its trials were no higher than "background" ones for people with ulcerative colitis, clearing a key safety concern.
    BioPharma Dive · 1mo ago↗ source
  • Ipsen’s $450M blood cancer drug; FDA selects first cohort for “pre-check” pilot program
    The planned acquisition of Kartos Therapeutics would hand Ipsen a late-stage asset for myelofibrosis. Elsewhere, Sobi hit a regulatory setback and BeOne unveiled more positive Brukinsa data.
    BioPharma Dive · 1mo ago↗ source
  • Viridian may have edge over Amgen in eye drug showdown, analysts argue
    The FDA, through a new approval, gave Viridian's drug a label that some on Wall Street believe makes it well-positioned to compete against Tepezza in the thyroid eye disease market.
    BioPharma Dive · 1mo ago↗ source
  • These biotechs just landed big fundraising hauls. Here’s what they pitched to investors.
    Biotechs aimed at eye diseases, autoimmune conditions and longevity medicine have pulled in some of the largest capital raises so far this year.
    BioPharma Dive · 1mo ago↗ source
  • Beeline ups its Series A round for immune drug work
    The company, which was built by Bain Capital, has now raised more than $426 million in its quest to advance a portfolio of Bristol Myers drugs.
    BioPharma Dive · 1mo ago↗ source
  • Top FDA gene and cell therapy regulator to step down
    Following Vijay Kumar’s exit, acting CBER Director Karim Mikhail will also oversee a review office that has become a battleground for debates on FDA flexibility.
    BioPharma Dive · 1mo ago↗ source
  • Theravance, after clinical setbacks, agrees to $929M buyout
    The acquisition by royalty management company Zymeworks follows a "strategic review" triggered by the failure of a drug for a type of low blood pressure.
    BioPharma Dive · 1mo ago↗ source
  • 10 clinical trials to watch in the second half of 2026
    The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.
    BioPharma Dive · 1mo ago↗ source
  • La Ceiba Foods Latin Market Inc. Recalls Cottage Cheese Products Because of Possible Health Risk
    June 26, 2026, – La Ceiba Foods Latin Market Inc. is conducting a recall of Requesón Salvadoreño (Salvadoran Cottage Cheese) and Requesón Mexicano (Mexican Cottage Cheese) products marketed under t…
    fda recalls · 1mo ago↗ source
  • FDA accepts Replimune filing; Merck KGaA drops $11B on life sciences services
    Replimune’s application is the latest example of changing attitudes at the FDA. Elsewhere, Revolution Medicines outlined more RAS-blocking data and a Definium stock offering brought in $800 million.
    BioPharma Dive · 1mo ago↗ source
  • At BIO, tension over China biotech deal regulation looms
    Biotech investors, executives and analysts worry that blanket bans on deals with Chinese companies could curb domestic entrepreneurs’ ambitions in the sector.
    BioPharma Dive · 1mo ago↗ source
  • Alkermes’ incoming CEO has a plan to outplay Lilly and Takeda
    Blair Jackson says the next 12 months may be the most important in Alkermes’ history, as the brain drugmaker races to join an “orexin” market that analysts see as a multibillion-dollar opportunity.
    BioPharma Dive · 1mo ago↗ source
  • On second try, Acadia drug gets nod from European regulators
    The influential CHMP committee also threw its support behind more than a dozen other medicines while recommending the marketing authorization for Tavneos be revoked.
    BioPharma Dive · 1mo ago↗ source
  • Moderna flu vaccine wins unanimous support from FDA panel
    The endorsement of an advisory committee positions Moderna to complete a dramatic turnaround for a shot the FDA declined to review earlier this year.
    BioPharma Dive · 2mo ago↗ source
  • cAMPfield lands $180M to build gut disease drug
    The biotech is advancing an anti-inflammatory drug that originated with vTv for inflammatory bowel diseases, leaning on a better side effect profile.
    BioPharma Dive · 2mo ago↗ source
  • Biogen adds more immune drugs in $1B buyout of secretive startup RayThera
    The companies didn’t specify the drugs Biogen is acquiring in the deal, though patents RayThera secured provide important clues.
    BioPharma Dive · 2mo ago↗ source
  • Pfizer CFO to step down; Denali sells a regulatory fast-pass
    A search is underway for a successor to Dave Denton, who took a job outside the pharmaceutical industry. Elsewhere, a new kind of Duchenne gene therapy got venture backing and a GSK deal paid divid…
    BioPharma Dive · 2mo ago↗ source
  • Kardigan extends biotech’s streak of big IPOs with $400M haul
    Including the heart drug developer’s offering, four biotechs in 2026 have raised at least $400 million in IPO proceeds — the most in a single year since 2021, according to BioPharma Dive data.
    BioPharma Dive · 2mo ago↗ source
  • UniQure to file gene therapy for approval, reflecting major shifts at FDA
    The decision marks another regulatory U-turn following the exits of Marty Makary and Vinay Prasad, suggesting to some analysts that current FDA leadership may be more flexible in certain cases.
    BioPharma Dive · 2mo ago↗ source