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408 stories matching this filter · ← front page

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  • Scribe secures $129M in a rare gene editing IPO
    <figure><div><img src="https://imgproxy.divecdn.com/v0D5Ajbuzjf7G4SQRuR5yVFGXoGWXxkevKZwUQRcJjs/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMTU2MTc2MTM5LmpwZ…
    BioPharma Dive · 6h ago↗ source
  • FDA panel endorses broader use of certain peptides
    <figure><div><img src="https://imgproxy.divecdn.com/d2JyuXgmLsPVrlZlLVlPLECICsiII5W1r34tQBQf49c/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xMjI3NzEwNTIwX0w2O…
    BioPharma Dive · 6h ago↗ source
  • Lilly, with new data, to seek FDA approval of obesity drug retatrutide
    <figure><div><img src="https://imgproxy.divecdn.com/x5fF_ZCHHBjPFAGFuuKXSVkAgBGYTo2hZBIz9OcQdEo/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMDkyNDczMjEzLmpwZ…
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Hematology6
Pulmonology5
Infectious Disease4
Ophthalmology3
Dermatology2
BioPharma Dive · 15h ago
↗ source
  • Recon: J&J nabs FDA authorization for general surgery robot; FDA urged to ban DTC drug ads
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 1d ago↗ source
  • Euro Roundup: EMA seeks feedback on planned changes to guidance on biosimilar efficacy studies
    <p>The European Medicines Agency (EMA) has released a draft concept paper on planned changes to its guideline on similar biological medicinal products.</p>
    raps · 1d ago↗ source
  • Study: Most sponsors complete postmarketing trials, publish results
    <p>Postmarketing requirements and commitments were completed for nearly nine out of ten drugs approved by the US Food and Drug Administration, with such requirements or commitments assigned at the…
    raps · 1d ago↗ source
  • FDA advisory committee backs two controversial peptides
    <p>An advisory committee to the US Food and Drug Administration (FDA) voted 8-6 with one abstention on Thursday to recommend that two peptides – BPC-157 to treat ulcerative colitis and KPV for woun…
    raps · 1d ago↗ source
  • Vertex was sole bidder in high-premium Crinetics acquisition
    <p>Analysts expect new details on the lead-up to the deal “are likely to reignite” investor scrutiny that Vertex overpaid in what’s poised to be its largest-ever transaction.</p>
    BioPharma Dive · 1d ago↗ source
  • GSK lung cancer drug gets speedy approval following $10.6B deal
    <figure><div><img src="https://imgproxy.divecdn.com/c0irKiK7j9tqBFXMPegw7r6KQcBI9zHl6OgHMT-b53A/g:nowe:0:353/c:4765:2692/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9OZXdfR1NLSC5qc…
    BioPharma Dive · 1d ago↗ source
  • Arrowhead hits ‘best-case scenario’ with latest results for fat-lowering drug
    <figure><div><img src="https://imgproxy.divecdn.com/8hRa8ccyqK4EhEh4oXaIz1XS7XE4MZBhJhutfBJVSSU/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xNzUyMzcxMjg5LmpwZ…
    BioPharma Dive · 1d ago↗ source
  • Trump threatens tariffs on imported generic drugs
    <figure><div><img src="https://imgproxy.divecdn.com/FZSdFBL2W8A453vDL0XpB2NIs52eHj5QA0Y0T_Dy_Bs/g:nowe:0:0/c:3200:1807/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0…
    BioPharma Dive · 1d ago↗ source
  • Summit counters PD-1/VEGF skeptics; Celldex drug fails skin disease study
    <figure><div><img src="https://imgproxy.divecdn.com/idsdMAHsPbXObDUtQW2qRG7uveBUVv6HCTn9NTtlDOI/g:nowe:0:0/c:1207:682/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0x…
    BioPharma Dive · 1d ago↗ source
  • Crystalys nets $130M more to push gout drug through late-stage tests
    <figure><div><img src="https://imgproxy.divecdn.com/THeKNpwt2ETxP7Nf-ec1mU-DtgG84p4ktQEqFznWC1c/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xODUxMTEwNjQucG5n.…
    BioPharma Dive · 1d ago↗ source
  • MDCG: Only manufacturers should assign UDI-DIs
    <p>The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be bet…
    raps · 2d ago↗ source
  • FDA issues untitled letters to Sanofi and Viatris for false advertising
    <p>The FDA’s Office of Prescription Drug Promotion recently reprimanded Sanofi and Viatris for making misleading claims about their products in emails and a television advertisement.</p>
    raps · 2d ago↗ source
  • Agios scraps sickle cell drug
    <figure><div><img src="https://imgproxy.divecdn.com/IiZTvtDA9eY9PoU6z9Ed0haIV_AWxuu_mTZM3XObZMk/g:nowe:0:88/c:4896:2766/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy…
    BioPharma Dive · 2d ago↗ source
  • Novo sues Lilly, alleging ‘misleading’ advertising of obesity drugs
    <figure><div><img src="https://imgproxy.divecdn.com/kw1AmHZ9iuWuwJs64qGVc7NH8w1twh5k8aIFqw3zDIg/g:nowe:0:388/c:5567:3145/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlc…
    BioPharma Dive · 2d ago↗ source
  • Dimension restocks with $800M to capitalize on AI’s ‘rapid ascent’
    <p>The young venture firm, which has bet heavily on tech and biotech’s convergence, has now invested in 35 companies and recently saw one of them acquired by AI giant Anthropic.</p>
    BioPharma Dive · 2d ago↗ source
  • Novartis climbs on upbeat drug sales as key readouts loom
    <figure><div><img src="https://imgproxy.divecdn.com/zfRhQ6UdoLhrnrg6WnOJHxS_autlpVcZwuWId9Q7ZSI/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0yMjA5Nzg4MDE4LmpwZ…
    BioPharma Dive · 2d ago↗ source
  • Recon: Novo sues Lilly over weight-loss drug ads; Gilead, Merck say HIV pill keeps HIV suppressed in two Phase 3 trials
    <p>Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.</p>
    raps · 3d ago↗ source
  • FDA cites companies for CGMP violations, informed consent failure
    <p>The US Food and Drug Administration has issued warning letters to several drug makers for failing to meet its current good manufacturing practices (CGMP) requirements and a company for failing t…
    raps · 3d ago↗ source
  • European Commission publishes guideline on transparency obligations under AI Act
    <p>The European Commission on Monday published new guidelines to assist providers and deployers of artificial intelligence (AI) systems in fulfilling transparency obligations under the EU’s AI Act,…
    raps · 3d ago↗ source
  • Tempus to acquire cancer test maker Personalis for $1.5B
    <figure><div><img src="https://imgproxy.divecdn.com/_RbdDztrnLOoumxY2iZaJMnVrx0w3LSgoNSRO_aqxDg/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xMjE4Nzk4MTY3LmpwZ…
    BioPharma Dive · 3d ago↗ source
  • Tempus to buy cancer test-maker Personalis for $1.5B
    <figure><div><img src="https://imgproxy.divecdn.com/_RbdDztrnLOoumxY2iZaJMnVrx0w3LSgoNSRO_aqxDg/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xMjE4Nzk4MTY3LmpwZ…
    BioPharma Dive · 3d ago↗ source
  • Pain drugmaker Latigo outlines plans to go public
    <figure><div><img src="https://imgproxy.divecdn.com/szYDL8kkQd6XaSVgvjJPYl2j0snveijWs_0sZ-B522Y/g:ce/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0xNDYyODUzODA3LmpwZ…
    BioPharma Dive · 3d ago↗ source