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251 stories matching this filter · ← front page

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  • AI data becomes sticking point in biopharma dealmaking
    As drug hunting gets more complex, where and how data is generated in partnerships between Big Pharmas and AI biotechs is becoming a headache for dealmakers.
    BioSpace · 9d ago↗ source
  • Wainua flop narrows AstraZeneca’s path to $80B goal ahead of high-risk readouts
    With a Phase 3 failure denting the rare disease drug’s prospects, AstraZeneca has little room for error as it plots a path toward its ambitious 2030 sales target.
    BioSpace · 9d ago↗ source
  • MDCG: Only manufacturers should assign UDI-DIs
    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 better…
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Nephrology238
raps · 9d ago
↗ source
  • FDA issues untitled letters to Sanofi and Viatris for false advertising
    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.
    raps · 9d ago↗ source
  • ‘We’re moving quickly’: Startup bags rare disease drug as Thiel-backed CEO eyes $50M fundraise
    A rare disease startup with a mission to repurpose proven drugs has licensed a Chinese formulation of a well-known medicine and set its sights on a $50 million fundraise.
    Fierce Biotech · 9d ago↗ source
  • Samsung Biologics targets $1.8B PolyPeptide buyout to expand in obesity
    With PolyPeptide manufacturing peptides such as GLP-1 medicines, Samsung Biologics has identified the deal as a way to tap into fast-growing demand for obesity drug production services.
    BioSpace · 10d ago↗ source
  • Biotech industry leaders file brief backing FDA against ‘malicious’ mifepristone challenge
    A group of 61 biopharma companies, executives and investors has filed an amicus brief in support of the FDA in an ongoing case brought by Louisiana meant to remove access to the abortion pill mifep…
    Fierce Biotech · 10d ago↗ source
  • Agios axes next-gen sickle cell candidate after it fails to best Novo’s asset
    Agios Pharmaceuticals’ sickle cell disease candidate didn’t prove any better than Novo Nordisk’s investigational PK activator or the biopharma’s own asset that is currently under FDA review for the…
    BioSpace · 10d ago↗ source
  • Crystalys mines $130M series B to push gout drug through phase 3
    Crystalys Therapeutics has raised $130 million in series B financing to advance the development of its gout drug dotinurad and prepare for a potential commercial launch.
    Fierce Biotech · 10d ago↗ source
  • Novartis stays 'geography-agnostic' in dealmaking amid flurry of China deals
    Novartis will continue to be on the lookout for bolt-on deals below $2 billion, CEO Vas Narasimhan said Tuesday on the pharma's second quarter earnings call—though major pickups aren’t completely o…
    BioSpace · 10d ago↗ source
  • ‘We’ve been looking for a novel approach’: Why Novartis CEO ended ADC holdout for $1.5B Myricx deal
    For years, as Big Pharma poured billions into ADCs, Novartis CEO Vas Narasimhan notably stayed on the sidelines. Asked by Fierce during Novartis’ Q2 earnings call, Narasimhan explained why he is en…
    Fierce Biotech · 10d ago↗ source
  • The FDA’s 505(b)(2) pathway is an underestimated engine of value creation
    The biopharma industry would do well to re-embrace the 505(b)(2) path, which allows sponsors to draw on previous findings around an existing drug even as they propose modifications to it.
    BioSpace · 10d ago↗ source
  • Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ review
    If approved, Dyne Therapeutics’ zeleciment rostudirsen could “capture the majority” of the exon-51 Duchenne muscular dystrophy market, given its better efficacy and dosing profile versus Sarepta Th…
    BioSpace · 10d ago↗ source
  • Axiom plans Hong Kong IPO, hoping to carve new path for US biotechs
    Axiom Biosciences is thinking outside of the box, betting on a public debut in Hong Kong to raise capital and grow into a global company.
    BioSpace · 10d ago↗ source
  • Jupiter enters psychedelics space with $100M deal for PharmAla's MDMA drug
    Jupiter Neurosciences will pay $3.3 million upfront to Canada's PharmAla Biotech for U.S. rights to an MDMA drug to treat neuropsychiatric disorders.
    Fierce Biotech · 10d ago↗ source
  • Agios says adios to sickle cell program over lackluster phase 2 data
    A phase 2 study of Agios Pharmaceuticals’ next-generation pyruvate kinase activator has failed to support continued development in sickle cell disease, leading the company to ax an indication for t…
    Fierce Biotech · 10d ago↗ source
  • Novartis drops phase 2 radioligand therapy, but CEO’s commitment to modality ‘unchanged’
    Novartis has dropped a phase 2-stage radioligand therapy after the candidate disappointed in the clinic.
    Fierce Biotech · 10d ago↗ source
  • Indian generics maker Lupin seeds US spinout Kaveri with cash, clinical-phase cancer assets
    Lupin has spun out two clinical-phase cancer drug candidates to create Kaveri Therapeutics, a U.S.-based startup that plans to raise cash for further development. Kaveri’s programs hit targets purs…
    Fierce Biotech · 10d ago↗ source
  • Roche taps Foundation Medicine’s chief as new North America Diagnostics lead, creates new commercial role
    Dan Malarek is leaving his role as chief executive of Roche’s sequencing subsidiary Foundation Medicine as he takes up the mantle as President and CEO of Roche Diagnostics North America.
    Fierce Biotech · 10d ago↗ source
  • Recon: Novo sues Lilly over weight-loss drug ads; Gilead, Merck say HIV pill keeps HIV suppressed in two Phase 3 trials
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 10d ago↗ source
  • FDA cites companies for CGMP violations, informed consent failure
    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 to s…
    raps · 10d ago↗ source
  • European Commission publishes guideline on transparency obligations under AI Act
    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, in…
    raps · 10d ago↗ source
  • Lilly’s AtaiBeckley buy validates space as Big Pharma takes note of psychedelics
    Eli Lilly’s proposed acquisition of AtaiBeckley is “the clearest strategic validation to date” of psychedelics as an emerging pharmaceutical category, according to H.C. Wainwright. The analyst caut…
    BioSpace · 11d ago↗ source
  • ‘There is always a first’: Why US biotech Axiom will begin its IPO journey in Hong Kong
    Axiom Biosciences intends to pursue an IPO on the Hong Kong Stock Exchange (HKEX), followed by a co-listing on the Nasdaq—a strategy the company claims is the first U.S. biotech to use.
    Fierce Biotech · 11d ago↗ source
  • FDA’s radical transparency policy for rejections runs into legal uncertainty
    Having started to publish CRLs without consulting the public, the FDA is under pressure to change course amid concerns it failed to openly and fully evaluate a complex issue.
    BioSpace · 11d ago↗ source