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853 stories matching this filter · ← front page

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  • Argenx to acquire Unnatural Products' macrocyclic peptide platform for $550 million upfront
    Argenx announced that it will acquire the California-based protein specialist Unnatural Products, paying $550 million upfront for its macrocyclic peptide platform. The deal could rise to more than…
    BioPharma Dive · 2h agoDealPositive↗ source
  • FDA orders label warnings for GLP-1 drugs over rare eye-loss risk
    The U.S. Food and Drug Administration has issued a safety communication that requires all glucagon-like peptide-1 receptor agonist (GLP-1 RA) products to add new warnings to their labeling. The ad…
    fda medwatch · 14h agoRegulatoryNegative↗ source
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fda medwatch107
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  • Abiomed issues recall of Automated Impella Controllers due to safety risk
    Abiomed has announced a recall of certain Automated Impella Controllers (AIC) after a review of service records. The FDA classified the recall as the most serious type, warning that continued use…
    fda medwatch · 14h agoCRLNegative↗ source
  • Phase II success does not guarantee easy Phase III launch, says Thermo Fisher
    Positive Phase II data often signals the start of Phase III planning, but the transition involves far more than simply adding patients and sites. When a trial expands into new countries, differenc…
    BioPharma Dive · 9h agoNeutral↗ source
  • State incentives can shape site decisions for commercial-stage life sciences firms
    The article advises commercial-stage life-science companies to consider state and local incentives early in expansion planning to improve site selection and preserve capital. Incentives most relev…
    BioPharma Dive · 9h agoNeutral↗ source
  • Early technical expertise key to tackling complex life-science construction projects
    Life‑science construction projects often present problems that lack obvious solutions, such as retrofitting existing buildings, using unconventional materials, or fitting large process equipment in…
    BioPharma Dive · 9h agoPositive↗ source
  • Biotech controversies cloud Vivek Ramaswamy’s Ohio governor campaign
    Vivek Ramaswamy, a former biotech entrepreneur, was defeated in Ohio’s governor race, a loss that coincided with heightened scrutiny of his industry background. Six biotech leaders publicly asked…
    BioPharma Dive · 3h agoNegative↗ source
  • Vir hepatitis D drug succeeds in first pivotal study
    A program that’s survived Vir’s pivot away from infectious disease research hit all of its study objectives and appeared more potent than a rival drug also in late-stage development.
    BioPharma Dive · 2h ago↗ source
  • FDA probes cancer risk from Zolgensma gene therapy after post-marketing tumor reports
    The FDA has issued a safety communication indicating it is investigating reports of malignancies in patients treated with Zolgensma, the adeno‑associated virus gene therapy for spinal muscular atro…
    fda medwatch · 3d agoRegulatoryNegative↗ source
  • Novartis reports nine cancer cases in patients treated with Zolgensma gene therapy
    Novartis disclosed that nine individuals with spinal muscular atrophy who received its gene therapy Zolgensma later developed tumors. Two of the cases showed evidence that the adeno-associated vir…
    BioPharma Dive · 3d agoRegulatoryNegative↗ source
  • Eli Lilly partners with Hims & Hers to sell Zepbound and Foundayo via telehealth platform
    Eli Lilly announced a partnership with Hims & Hers to make its obesity treatments Zepbound and Foundayo available through the telehealth service. The arrangement lets patients with a prescription…
    BioPharma Dive · 3d agoDealNeutral↗ source
  • Novo Nordisk’s oral Wegovy sales beat forecasts, boosting shares over 5%
    BioPharma Dive’s latest visualization series examines how investors reacted to three drug launches highlighted in recent quarterly earnings. Novo Nordisk reported that its oral Wegovy generated 5.…
    BioPharma Dive · 3d agoPositive readoutPositive↗ source
  • Regulators urge risk-based lifecycle approach for AI tools amid election-linked FDA uncertainty
    A panel of regulatory experts at the RAPS AI in Regulatory Conference in Barcelona urged professionals using AI tools to adopt a risk-based, life-cycle perspective rather than focusing solely on va…
    raps · 3d agoRegulatoryNeutral↗ source
  • Regulatory experts urge risk-based, lifecycle validation for AI tools in FDA work
    At the RAPS AI in Regulatory Conference in Barcelona, a panel of experts discussed the growing use of AI tools by regulatory professionals. They recommended a risk-based, lifecycle approach to val…
    raps · 3d agoRegulatoryNeutral↗ source
  • Revolution Medicines reports $198 million Q3 sales for pancreatic cancer drug Rasonque, calling it best oncology launch ever
    Revolution Medicines' new pancreatic cancer drug Rasonque generated $198 million in revenue in the third quarter, far exceeding analyst expectations of $50‑100 million. The drug received FDA appro…
    BioPharma Dive · 4d agoPositive↗ source
  • Medicare to slash 340B drug payments and expand site-neutral rules in 2027
    Medicare finalized a rule that will cut payments for drugs covered by the 340B discount program and broaden site-neutral payment policies beginning in 2027. The rule is expected to reduce Medicare…
    BioPharma Dive · 3d agoRegulatoryNegative↗ source
  • J&J and AbbVie present early trispecific antibody data for multiple myeloma at ASH meeting
    At the American Society of Hematology (ASH) meeting, Johnson & Johnson and AbbVie are slated to share early clinical data on trispecific antibodies targeting multiple myeloma. These next‑generation…
    BioPharma Dive · 4d agoPositive readoutPositive↗ source
  • T-Therapeutics secures $133 million Series B to advance bispecific cancer and autoimmune drugs
    T-Therapeutics, a UK-based biotech focused on T-cell engager technology, announced a $133 million Series B financing. The capital will be used to generate proof-of-concept data for its lead bispec…
    BioPharma Dive · 4d agoDealPositive↗ source
  • Alethio Therapeutics secures $90 million to develop treatments for rare blood cancers
    Alethio Therapeutics, a UK based biotechnology startup, announced it has raised $90 million in new financing. The capital will be used to advance its pipeline targeting myeloproliferative neoplasm…
    BioPharma Dive · 4d agoDealPositive↗ source
  • MDCG issues guidance on clinical evidence for orphan in-vitro diagnostics
    The Medical Device Coordination Group (MDCG) has published new guidance that explains how clinical evidence requirements apply to orphan in-vitro diagnostics (IVDs). The document is intended to he…
    raps · 4d agoRegulatoryNeutral↗ source
  • Experts urge streamlined EU AI framework and higher regulatory literacy for healthcare products
    Experts speaking at the RAPS AI in Regulatory Conference in Barcelona called for a more streamlined artificial intelligence framework for healthcare products across Europe. They said the current r…
    raps · 4d agoRegulatoryNeutral↗ source
  • FDA official says midterm elections unlikely to delay user fee reauthorization for FY 2028-2032
    A senior FDA official indicated that the recent midterm election results are not expected to interfere with the upcoming renewal of the agency’s user fee contracts covering fiscal years 2028 throug…
    raps · 4d agoRegulatoryNeutral↗ source
  • Recon: Sino, Boehringer ink cancer drug deal worth $7B; CVS to split pharmacy business from insurance
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 4d ago↗ source
  • Novo Nordisk lifts 2026 profit outlook after Wegovy obesity pill beats forecasts
    Novo Nordisk announced on Wednesday that it is raising its full-year profit and sales guidance after the third-quarter results for its Wegovy obesity pill came in above analysts' expectations. The…
    BioPharma Dive · 5d agoEarningsPositive↗ source
  • CVS to split into two companies, separating Aetna and Caremark from its retail pharmacies
    CVS Health announced it will divide the business into two independent companies, one that will contain its insurance unit Aetna and pharmacy‑benefit manager Caremark, and another that will operate…
    BioPharma Dive · 5d agoNeutral↗ source