pharmadog
News
when
  • Latest
  • Archive
by source
  • All Sources
  • Sources Page
Jobs
department
  • Clinical
  • Regulatory
  • Medical Affairs
  • Commercial
  • R&D / Discovery
  • Biostatistics / Data
  • Manufacturing / CMC
  • Market Access
therapeutic area
  • Oncology
  • Immunology
  • Neuroscience
  • Cardiovascular
  • Metabolic
  • Rare Disease
  • Infectious Disease
location & type
  • Remote Only
  • US Only
  • California
  • Massachusetts
  • Internships
  • Phase 3 Roles
  • All Jobs →
Drugs
by stage
  • Marketed
  • Phase 3
  • Phase 2
  • Phase 1
  • Preclinical
browse
  • Most catalysts
  • Recently active
  • All drugs →
  • Companies
  • Patent cliff
Calendar
what
  • Trial readouts
  • PDUFA dates
  • Approvals
  • Earnings
when
  • Upcoming
  • Month grid
  • Recently passed
Sign InSubscribe
pharmadog

fetch the data · sniff the signal

Discover
  • Jobs
  • News
  • Drugs
  • Calendar
  • Companies
Hubs
  • Topics
  • Patent cliff
  • Publications
  • Readouts
Tools
  • Compare
  • Search
  • Bookmarks
Trust
  • About
  • Sources
  • Contact
Legal
  • Privacy
  • Terms
  • Pricing

© 2026 pharmadog.xyz

made by humans and a good dog

  • home
  • jobs
  • news
  • search
pharmadog news

Browse

668 stories matching this filter · ← front page

★ save view↓export CSV
rangeto
sort
recentoldestsourcealpha
source
STAT1760Endpoints1373Fierce Biotech693BioSpace686BioPharma Dive519raps227onclive165fda recalls
therapy area
allOncology12247Rare Disease3165Immunology2849Cardiology2694Hematology2136Pulmonology2133Vaccines
  • 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 · 15h agoRegulatoryNegative↗ source
  • 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 · 15h agoCRLNegative↗ source
← prev
page 1 of 27
next →
111
fda medwatch107
globenewswire health73
fda press58
1775
Psychiatry & CNS1197
Ophthalmology1027
Endocrinology & Metabolism770
Pain768
Nephrology757
  • Fresh & Ready Foods recalls 2,414 Fresh To You sausage, egg & cheese biscuit sandwiches over possible Listeria contamination
    Fresh & Ready Foods LLC of Renton, Washington announced a recall of 2,414 Fresh To You sausage, egg and cheese biscuit sandwiches after testing indicated a potential contamination with Listeria mon…
    fda recalls · 1d agoNegative↗ 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
  • 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
  • Eugia US recalls specific lot of vancomycin injection after glass particle found in vials
    Eugia US LLC, formerly Auro Medics Pharma, announced a voluntary nationwide recall of the vancomycin hydrochloride injection (1.25 g per 30 mL vial) for lot number 3VM26026A. The recall was trigge…
    fda recalls · 3d agoCRLNegative↗ 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
  • FDA grants accelerated approval for Rybrevant Faspro in recurrent/metastatic head and neck cancer
    The U.S. Food and Drug Administration granted accelerated approval to Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) for adults with recurrent or metastatic head and neck squamous cell carci…
    fda press · 3d agoApprovalPositive↗ 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
  • FDA urges biosimilar sponsors to use alternative efficacy studies while AI reshapes regulatory work
    AI is becoming common in regulatory work. Experts say it will not replace regulatory professionals but will help them work more efficiently and free up time for human interaction. They stress that…
    raps · 5d agoRegulatoryNeutral↗ source
  • FDA urges biosimilar makers to adopt alternatives to clinical efficacy trials
    FDA's Office of Therapeutic Biologics and Biosimilars, led by director Sarah Yim, announced that the agency is working to help sponsors rely less on clinical efficacy studies when developing biosim…
    raps · 5d agoRegulatoryPositive↗ source
  • Compact Medical issues recall and updated instructions for ButterflyBVM bag-valve-mask resuscitators due to bellows holes
    The FDA's Center for Devices and Radiological Health has issued an early alert about a potential high‑risk problem with certain Compact Medical ButterflyBVM bag‑valve‑mask devices. Compact Medical…
    fda medwatch · 6d agoCRLNegative↗ source
  • Legal experts advise European healthcare manufacturers on navigating complex environmental regulations
    At the RAPS Regulatory Intelligence Conference Europe in Barcelona, two legal specialists highlighted the difficulty of Europe’s environmental and sustainability rules for companies that make healt…
    raps · 6d agoRegulatoryNeutral↗ source
  • FDA reports rise in unannounced drug inspections in China and India for FY 2026
    A senior FDA enforcement official said the agency carried out more surprise drug facility inspections in India and China during fiscal year 2026 than it did in the prior year. The unannounced visi…
    raps · 6d agoRegulatoryNeutral↗ source
  • Stakeholders submit over 500 comments urging FDA to shape regulation of generative AI medical devices
    Over 500 comments have been filed in response to the FDA's discussion paper on generative AI-enabled medical devices. The feedback reflects a wide range of viewpoints. Some participants recommend…
    raps · 6d agoRegulatoryNeutral↗ source
  • Recon: Merck KGaA to exit CDMO business; Karyopharm to sell itself in bankruptcy
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 6d ago↗ source
  • FDA issues final guidance on potency assurance for cell and gene therapy manufacturers
    The FDA released final guidance today outlining a science- and risk-based Potency Assurance Strategy for cellular and gene therapy (CGT) products. The guidance replaces the agency’s 2011 potency t…
    fda press · 7d agoRegulatoryNeutral↗ source
  • FDA issues final guidance on potency standards for cell and gene therapy developers
    The U.S. Food and Drug Administration released a final guidance on Monday that sets out the expectations for sponsors of cell and gene therapies to demonstrate product potency. The document requir…
    raps · 7d agoRegulatoryNeutral↗ source
  • FDA approves generic lenacapavir for low-income markets; EMA to review Lundbeck's Deanxit over safety concerns
    The U.S. Food and Drug Administration has granted approval for a generic version of lenacapavir, a drug aimed at treating HIV, with the intention of making it available to lower-income countries.…
    raps · 7d agoApprovalNeutral↗ source
  • Early Alert: B. Braun Medical Inc. Removes Streamline Bloodline Set for Dialog+
    The dialyzer connector may not be attached appropriately, resulting in leaking and potential blood loss.
    fda medwatch · 7d agoRegulatoryNeutral↗ source
  • Study finds patient agreement forms match knowledge surveys, urging greater transparency in FDA’s mifepristone REMS
    A randomized controlled trial published in JAMA Internal Medicine examined how well patients understood medication abortion when they signed the FDA’s risk evaluation and mitigation strategy (REMS)…
    raps · 7d agoRegulatoryNeutral↗ source
  • Australian regulator opens consultation on clinical trial data sharing and ICH GCP guidance
    The Therapeutic Goods Administration (TGA) in Australia has launched a public consultation seeking input on how clinical trial information should be shared under existing schemes. The consultation…
    raps · 7d agoRegulatoryNeutral↗ source