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15 stories matching this filter · ← front page

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allOncology7275Rare Disease1816Cardiology1639Immunology1443Hematology1290Vaccines1172Pulmonology1080
  • Ionis receives FDA approval for Zanvastro, the first treatment for Alexander disease, as Pfizer partners on new ADC program
    The U.S. Food and Drug Administration approved Zanvastro, marking the first approved medicine for the rare and often fatal neurological disorder Alexander disease. Developed by Ionis Pharmaceutical…
    BioPharma Dive · 2d agoApprovalPositive↗ source
  • AbbVie’s dual-acting myeloma drug etentamig meets main Phase 3 goal, showing longer progression-free survival
    AbbVie announced that its bispecific antibody etentamig achieved the primary endpoint in a Phase 3 trial for patients with multiple myeloma who have progressed after two or more prior therapies. Th…
    BioPharma Dive · 2d agoPositive readoutPositive
73
fda recalls67
fda medwatch59
fda press38
Psychiatry & CNS856
Ophthalmology488
Pain463
Endocrinology & Metabolism457
Infectious Disease436
↗ source
  • FDA approves Priovant's Lisraya (brepocitinib) for rare skin disease dermatomyositis
    The U.S. Food and Drug Administration has cleared the first oral targeted treatment for dermatomyositis, a rare and disabling skin disorder. The medication, brepocitinib, will be sold under the br…
    BioPharma Dive · 9d agoApprovalPositive↗ source
  • Gilead reports modest sales rise but analysts question future growth beyond HIV drugs
    Gilead's second‑quarter results showed total product revenue of $7.6 billion, up 8% year‑over‑year. The company's two leading HIV treatments, Biktarvy and Descovy, together generated about $5.7 bi…
    BioPharma Dive · 1mo agoEarningsNeutral↗ source
  • Pfizer expands cost-cutting program, targeting $1 billion in new savings through 2029
    Pfizer announced it is expanding a cost-cutting initiative first launched in 2023 to further reduce expenses. The new measures are projected to generate about $1 billion in additional savings by 2…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Pfizer CFO Dave Denton to leave; Denali Therapeutics sells $195 million FDA priority review voucher
    Pfizer announced that its chief financial officer Dave Denton will depart on Aug. 15 to take a role outside the pharmaceutical sector. He has been CFO since May 2022. In the interim, finance chief…
    BioPharma Dive · 2mo agoDealNeutral↗ source
  • Lilly’s retatrutide data at ADA 2026 underscores its lead in obesity drug market
    The American Diabetes Association’s 2026 meeting highlighted a wave of new weight‑loss drug data as companies vie for a slice of a market dominated by Eli Lilly and Novo Nordisk. Lilly presented r…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Otsuka showcases kidney drug data; Pfizer cuts an AI deal
    Voyxact helped preserve kidney function, but left an opening for competing IgAN drugs from Vera and Vertex. Elsewhere, Takeda’s alliance with Innovent paid early dividends and Axsome warded off gen…
    BioPharma Dive · 3mo agoDealNeutral↗ source
  • Bipartisan House bill would require security review of U.S. biotech investments in China
    A bipartisan group of Representatives introduced legislation on Tuesday that would expand the Committee on Investment and National Security (COINS) Act to cover biotechnology. The bill, called the…
    BioPharma Dive · 3mo agoRegulatoryNeutral↗ source
  • Fulcrum Therapeutics considers sale after FDA blocks sickle cell drug development
    Fulcrum Therapeutics announced it is undertaking a strategic review that could lead to a sale after its lead sickle cell candidate, pociredir, was effectively blocked by the FDA. The agency cited…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • Pfizer partners with China's Innovent Biologics on $10 billion cancer drug collaboration
    Pfizer announced a major partnership with Chinese biotech Innovent Biologics, valued at over $10 billion, to develop cancer therapies. The agreement covers up to 12 antibody-based candidates, incl…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Arvinas, Pfizer find new partner for ‘Protac’ breast cancer drug
    A deal with Rigel Pharmaceuticals ends months of uncertainty about the future of Veppanu, a first-of-its-kind, newly approved medicine with a murky financial outlook.
    BioPharma Dive · 3mo ago↗ source
  • Arvinas’ ‘Protac’ breast cancer drug cleared by FDA
    Known as Veppanu, the drug is the first of its kind to get to market. But Arvinas and partner Pfizer are still searching for a new partner to sell it.
    BioPharma Dive · 4mo ago↗ source
  • FDA tests out ‘real-time’ clinical trials; AbbVie closes in on a KRAS biotech
    Through two pioneering studies, Amgen and AstraZeneca will share study data with FDA scientists as it’s accrued. Elsewhere, Lilly inked a gene editing deal and Pfizer reported success for a multipl…
    BioPharma Dive · 4mo ago↗ source
  • Pfizer deals extend patent life for a top-selling rare disease drug
    Settlements delaying the arrival of generic versions of tafamidis will protect billions in Pfizer revenue and have implications for others, including BridgeBio Pharma and Alnylam.
    BioPharma Dive · 4mo ago↗ source