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8 stories matching this filter · ← front page

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STAT1155Endpoints871BioPharma Dive339BioSpace293Fierce Biotech275onclive165raps104globenewswire health
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allOncology7275Rare Disease1816Cardiology1639Immunology1443Hematology1290Vaccines1172Pulmonology1080Psychiatry & CNS
  • 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
  • Bristol Myers Squibb pauses autoimmune CAR‑T trials after life‑threatening side effects
    Bristol Myers Squibb announced in early June that it is pausing its CAR‑T therapy trials targeting autoimmune diseases after the trials reported life‑threatening side effects. The company informed…
    STAT · 2d agoRegulatoryNegative↗ source
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fda recalls67
fda medwatch59
fda press38
856
Ophthalmology488
Pain463
Endocrinology & Metabolism457
Infectious Disease436
  • 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
  • Medicare GUARD pilot faces biotech push to spare rare disease drugs as Moderna begins first-in-human Ebola vaccine trial
    The Medicare Part D GUARD pilot, designed to lower retail drug prices, is under scrutiny because excluding rare disease medicines would erase most of the projected savings, according to STAT. Biot…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Merger talks between Bristol Myers Squibb and AstraZeneca fade as Q2 earnings roll out and FDA advisory meetings heat up
    Talks of a possible merger between Bristol Myers Squibb and AstraZeneca have receded after analysts highlighted antitrust hurdles. Both companies, each valued over $130 billion, were rumored to con…
    BioSpace · 1mo agoDealNeutral↗ 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
  • STAT+: A patent win for Pfizer and BridgeBio
    A change to FDA clinical trial data review, Rocket sells its priority review voucher, and more biotech news from The Readout
    STAT · 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