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  • Scribe reels in nearly $129M in rare early-stage IPO for a gene editing biotech
    Jennifer Doudna–founded Scribe Therapeutics intends to use the proceeds from the public offering—the first for a gene editing outfit in over two years—to support development of its epigenetic silen…
    BioSpace · 5d ago↗ source
  • Biogen’s Alzheimer’s data spur excitement, confusion about tau-targeting drugs
    LONDON — One of the most anticipated Alzheimer’s studies in the past few years has created both enthusiasm and confusion, according to conversations Endpoints News recently had with about 20 scient…
    Endpoints · 5d ago↗ source
  • Amgen deploys patients to defend troubled Tavneos in FDA hearing request
    Facing pressure around the world to withdraw the rare kidney disease drug Tavneos, Amgen has launched a robust defense with real-world evidence to support the product’s benefit-risk profile.
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BioSpace · 5d ago↗ source
  • Novo asks court to block Lilly ads; Merck strikes HIV PrEP deal
    Plus news about Abbvie and Genmab, Johnson & Johnson and Mannkind. Novo urges court to block Lilly’s GLP-1 ads: Novo Nordisk asked a New Jersey federal court on Friday to temporarily block what it…
    Endpoints · 5d ago↗ source
  • STAT+: Fatal gene-editing trial in China raises ethics and oversight questions
    Sanofi insulin pen in short supply, a win for peptide compounds, and more biotech news from The Readout
    STAT · 5d ago↗ source
  • STAT+: Pharmalittle: We’re reading about an FDA panel and peptides, a Merck license for an HIV pill, and more
    In a win for peptide proponents, an FDA advisory panel recommended compounding pharmacies be allowed to make four of the drugs
    STAT · 5d ago↗ source
  • CHMP recommends Minoryx’s ALD drug, rejects Zevra’s Meplyffa
    Minoryx Therapeutics finally scored backing from EU regulators for its neurological drug that’s faced multiple hurdles. Meanwhile, Zevra’s rare disease drug got a setback in Europe almost two years…
    Endpoints · 5d ago↗ source
  • Lilly’s $3.8B psychedelics bet won’t open the M&A floodgates
    Eli Lilly’s $3.8 billion play for AtaiBeckley has fueled speculation that Big Pharma is ready to embrace psychedelics. But while the acquisition does validate the drug class, analysts say it is unl…
    BioSpace · 5d ago↗ source
  • Summit has less than a year of cash runway left as PD-1/VEGF verdict nears
    Summit’s star asset is the PD-1/VEGF bispecific ivonescimab, which this week produced promising survival data from a late-stage global trial in non-small cell lung cancer. The FDA review is ongoing…
    BioSpace · 5d ago↗ source
  • A new, separate outbreak of the diarrhea-causing parasite
    A win for peptide proponents, autism advisory committees clash, and more health news from Morning Rounds
    STAT · 5d ago↗ source
  • Roche cans one Carmot obesity asset as another shows best-in-class potential
    Acmopatide met the main goal of a Phase 2 study in type 1 diabetes, but Roche is axing the investigational drug to prioritize enicepatide for weight loss, type 2 diabetes and cardiovascular outcome…
    BioSpace · 5d ago↗ source
  • Michael Ehlers joins Formation Bio to lead R&D; Black Diamond co-founder dies at 67
    Michael Ehlers left his CEO role at Ascidian Therapeutics, the exon editing company he co-founded, to run R&D at the AI biotech Formation Bio. It’s not often that biotech executives leave ...
    Endpoints · 5d ago↗ source
  • STAT+: Merck strikes voluntary licensing deals in poor countries for an experimental HIV prevention pill
    Merck is striking licensing deals for its experimental HIV prevention pill in hope of getting wide-scale production started quickly.
    STAT · 5d ago↗ source
  • Sanofi nixes Kymab-originated OX40L antibody in atopic dermatitis
    Sanofi has decided to stop working on a drug for eczema it had hoped would be a successor to its immunological megablockbuster Dupixent. The French pharma said that it won’t seek ...
    Endpoints · 5d ago↗ source
  • Opinion: I may be one of the last middle-class medical students who could afford to become a doctor
    A federal loan program made it possible for Gauri Gurumurthy to pursue medicine. Now that program is changing.
    STAT · 5d ago↗ source
  • Opinion: The U.S. pharmaceutical supply chain problem is not about China
    The national security framing of the discussion around pharmaceutical supply chain vulnerabilities is a distraction, writes Pooja Yerramilli.
    STAT · 5d ago↗ source
  • Senate advances MAHA-friendly bill for food warning labels and junk food ad bans
    Unexpected alliances among Republicans and Democrats were on display over a bill meant to rein in ultra-processed foods.
    STAT · 5d ago↗ source
  • STAT+: White House offers its science blueprint: More AI, less life sciences
    The Trump administration released its blueprint for U.S. science, calling for shifting hundreds of billions of research dollars from universities to industry.
    STAT · 5d ago↗ source
  • Gene editor Scribe starts second-half IPO spree with $129M listing
    A nine-year-old biotech co-founded by CRISPR pioneer Jennifer Doudna is kicking off a run of biotech IPOs set for this year's second half. Scribe Therapeutics priced its $128.7 million
    Endpoints · 5d ago↗ source
  • STAT+: In win for RFK Jr., FDA advisory panel narrowly votes to allow compounding of unapproved peptides
    The panel recommended allowing compounding pharmacies to produce popular but unproven BPC-157 and KPV peptides.
    STAT · 5d ago↗ source
  • Updated: FDA adcomm backs popular wellness peptides, despite staff concerns
    An FDA advisory committee voted to recommend expanding access to popular peptides used by health and wellness enthusiasts for repairing muscles, healing injuries, boosting metabolism and reducing i…
    Endpoints · 5d ago↗ source
  • FDA to end pilot aimed at preventing production issues
    The FDA said it will end a pilot that was intended to help drugmakers proactively address production issues. Few companies took advantage of the program during its three-year run. In April 2027, th…
    Endpoints · 5d ago↗ source
  • Update: FDA does not freeze CRL trove as ‘radical transparency’ push hits speedbump
    An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.”
    BioSpace · 5d ago↗ source
  • U.S. health officials are investigating a new outbreak of a diarrhea-causing parasite
    Federal health officials are investigating a new outbreak involving the diarrhea-causing parasite cyclospora.
    STAT · 5d ago↗ source
  • STAT+: European regulators take steps to bolster clinical trial transparency
    The European Medicines Agency is taking what advocacy groups are calling unexpectedly “rapid action” to ensure that clinical trial results are made public as required by law.
    STAT · 6d ago↗ source