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412 stories matching this filter · ← front page

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  • Sanofi halts development of troubled immune drug in eczema
    <figure><div><img src="https://imgproxy.divecdn.com/FBR1IQNmU9Hqatva496Zg2G8JMHsqV0UGsf4LMARqYo/g:nowe:189:144/c:1776:1003/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS80OTY5MDc4Mzc…
    BioPharma Dive · 13h ago↗ source
  • Novo escalates legal fight with Lilly; J&J reinforces ‘dominance’ in multiple myeloma
    <figure><div><img src="https://imgproxy.divecdn.com/idsdMAHsPbXObDUtQW2qRG7uveBUVv6HCTn9NTtlDOI/g:nowe:0:0/c:1207:682/rs:fill:1600:900:1/Z3M6Ly9kaXZlc2l0ZS1zdG9yYWdlL2RpdmVpbWFnZS9HZXR0eUltYWdlcy0x…
    BioPharma Dive · 15h ago↗ source
  • 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…
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Hematology6
Pulmonology5
Infectious Disease4
Ophthalmology3
Dermatology2
BioPharma Dive · 1d 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 · 1d ago↗ source
  • This Week at FDA: Diamantas touts onshoring efforts, grants for DHTs, and more
    <p>Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug, and medical device regulation, and what we’re reading from around the web. This…
    raps · 1d ago↗ source
  • FDA advisory committee backs two more peptides, rejects one for compounding list
    <p>By the end of a two-day meeting that concluded Friday afternoon, an advisory committee to the US Food and Drug Administration (FDA) voted in favor of adding six of the seven peptides it was task…
    raps · 1d 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…
    BioPharma Dive · 1d 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 · 2d 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 · 2d 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 · 2d 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 · 2d 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 · 2d 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 · 2d 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 · 2d 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 · 2d 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 · 2d 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 · 2d 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 · 3d 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 · 3d 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 · 3d 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 · 3d 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 · 3d 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 · 3d 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 · 4d 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 · 4d ago↗ source