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  • GSK to close German vaccine plant and cut 650 jobs as flu vaccine demand falls
    GSK announced it will wind down its vaccine manufacturing site in Germany, ending operations at the facility. The decision follows a rigorous review and reflects a decline in demand for egg‑based…
    Endpoints · 22h agoLayoffsNegative↗ source
  • EMA says regulators pledge API inspection sharing but report modest progress
    The European Medicines Agency reports that regulators worldwide are strongly committed to sharing plans for good manufacturing practice inspections of active pharmaceutical ingredient suppliers. D…
    raps · 1d agoRegulatoryNeutral↗ source
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  • RAPS Convergence 2026 Highlights Future of Regulatory Science and Patient Safety
    The RAPS Convergence 2026 event gathered regulatory professionals to reflect on how the field has changed. Attendees discussed how emerging technologies are reshaping regulatory processes and expe…
    raps · 1d agoRegulatoryPositive↗ source
  • EMA issues new guideline on assessing gastrointestinal drug interaction risks
    The European Medicines Agency has released a guideline that outlines how to evaluate drug interactions that occur in the gastrointestinal (GI) tract. The document focuses on extrinsic factors such…
    raps · 1d agoRegulatoryNeutral↗ source
  • Novo Nordisk rebrands as 'Novo' and launches new culture strategy after recent setbacks
    Novo Nordisk announced it will drop "Nordisk" from its public brand, opting to be known simply as "Novo" starting Monday. The name change is part of a broader cultural overhaul aimed at revitalizi…
    Endpoints · 1d agoNeutral↗ source
  • Axoltis Phase 2 ALS Trial Fails Primary Endpoint Though Shows Some Secondary Trends
    Axoltis Pharma reported that its phase 2 study of the synthetic peptide NX210c in amyotrophic lateral sclerosis did not meet its primary goal. The double‑blind, randomized trial enrolled 82 French…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • Novo rebrands, drops 'Nordisk' to become simply 'Novo' in market push
    Novo Nordisk announced a major rebranding that will see the company drop the "Nordisk" part of its everyday brand. The legal name Novo Nordisk A/S remains unchanged, but the company will be known s…
    Fierce Biotech · 1d agoPositive↗ source
  • J&J nears $20 billion sale of DePuy Synthes orthopedics unit to Apollo
    Johnson & Johnson is in advanced talks to sell its DePuy Synthes orthopedics business to private-equity firm Apollo Global Management for roughly $20 billion, according to Bloomberg. The deal woul…
    Fierce Biotech · 2d agoDealNeutral↗ source
  • Akeso and Summit report survival advantage for PD-1xVEGF combo over Keytruda
    At the American Society of Clinical Oncology (ASCO) 2026 meeting, Akeso Biopharma and its partner Summit Therapeutics announced new survival results for their experimental PD‑1×VEGF bispecific anti…
    Endpoints · 2d agoPositive readoutPositive↗ source
  • GE HealthCare eyes $1 billion purchase of radiopharmaceutical developer Sofie Biosciences
    GE HealthCare is reported to be weighing a purchase of Sofie Biosciences, a radiopharmaceutical developer, for as much as $1 billion, according to the Financial Times. Sofie Biosciences, based in…
    Fierce Biotech · 2d agoDealNeutral↗ source
  • Novartis encounters setbacks while AI firm Anthropic searches for a dealmaker
    The latest Endpoints Weekly edition highlights a difficult period for Novartis, noting that the company is facing a series of setbacks. Details of the challenges are not provided, but the report s…
    Endpoints · 3d agoNeutral↗ source
  • Cullinan and Taiho report six-month survival gain for EGFR exon 20 NSCLC in phase 3 trial
    Cullinan Therapeutics and Taiho Oncology presented interim data from their phase 3 Rezilient3 study, which evaluated the tyrosine kinase inhibitor zipalertinib combined with platinum‑based chemothe…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • BioNTech's gotistobart shows 18.5-month median survival in relapsed squamous lung cancer, beating docetaxel
    BioNTech presented updated data from its phase 3 Preserve-003 trial at the World Conference on Lung Cancer in Seoul. The trial compares its anti-CTLA-4 antibody gotistobart with standard chemothera…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • GSK’s risvutatug rezetecan shows 18.5-month median overall survival in phase 3 SCLC trial
    GSK, together with Chinese partner Hansoh Pharma, reported results of its antibody‑drug conjugate risvutatug rezetecan (ris‑rez) in a phase 3 trial for relapsed small‑cell lung cancer. The study e…
    Fierce Biotech · 4d agoPositive readoutPositive↗ source
  • Definium Therapeutics clinches third phase-3 win for LSD anxiety drug, eyes FDA filing
    Definium Therapeutics reported another successful phase 3 trial of its LSD‑based anxiety treatment, DT120 ODT. The Panorama study enrolled 245 patients and compared a 100 µg dose of DT120 with pla…
    Fierce Biotech · 3d agoPositive readoutPositive↗ source
  • Revolution Medicines secures FDA approval for Rasonque, a RAS inhibitor targeting advanced pancreatic cancer
    Revolution Medicines announced FDA approval of its RAS inhibitor Rasonque for patients with advanced pancreatic cancer, marking a milestone for the company. The approval is seen as a breakthrough…
    Fierce Biotech · 4d agoApprovalPositive↗ source
  • Yarrow Bioscience raises $150M as AbbVie reports positive menstrual migraine trial results
    Yarrow Bioscience, based in New Haven, announced pricing of a $150 million equity offering at $26 per share, roughly $2.50 below the previous closing price. The capital raise will provide addition…
    Endpoints · 3d agoPositive readoutPositive↗ source
  • Trade group warns stalled biosimilar development could forfeit billions in savings
    A trade association that represents generic drug makers and biosimilar developers released a new report warning that progress on biosimilar products has slowed. The group says the slowdown threaten…
    Endpoints · 3d agoNegative↗ source
  • Centric Compounding recalls Glutathione, Myer’s Cocktail and Tri-Immune Boost injectables over elevated endotoxin levels
    Centric Compounding LLC announced a voluntary recall of six lots of its injectable products Glutathione 200 mg/mL, Myer’s Cocktail and Tri-Immune Boost. The recall was issued on September 9, 2026 a…
    fda recalls · 3d agoRegulatoryNegative↗ source
  • Takeda R&D chief Andy Plump to retire in 2027 as Novo Nordisk names Alex Hoffman global research head
    Takeda announced that its head of research and development, Andy Plump, will step down in June 2027. Plump, who joined Takeda from Sanofi in 2015 and has led R&D since December 2018, will retire af…
    Endpoints · 4d agoNeutral↗ source
  • FDA pushes back decision on Exelixis' zanzalintinib and Roche's Tecentriq combo for metastatic colorectal cancer
    The FDA announced a delay in its decision on the approval of Exelixis' oral kinase inhibitor zanzalintinib when used with Roche's Tecentriq for metastatic colorectal cancer. The agency said it nee…
    Fierce Biotech · 4d agoRegulatoryNegative↗ source
  • Alzheon seeks up to $500M in new financing after Phase 3 setback for Alzheimer’s drug
    Alzheon, a biotech based in Framingham, Massachusetts, has been pursuing an Alzheimer’s therapy for more than a decade. Its lead candidate recently failed to achieve the primary goals in a Phase 3…
    Endpoints · 3d agoDealNeutral↗ source
  • Owkin and Servier partner to use AI platform K Pro for oncology discovery and trial design
    Owkin, an AI drug-discovery CRO, has entered a new agreement with French pharmaceutical company Servier to license its AI scientist, K Pro, for use in Servier’s oncology research and clinical trial…
    Fierce Biotech · 4d agoDealPositive↗ source
  • FDA plans study on barriers to women's enrollment in pregnancy exposure registries and announces PRV fee rates
    The Food and Drug Administration said it will conduct research into perceived barriers that limit women’s participation in pregnancy exposure registries. It also released the fee schedule for prio…
    raps · 4d agoRegulatoryNeutral↗ source
  • FDA grants three-month review extension for Exelixis' metastatic colorectal cancer candidate
    Exelixis, a California drug developer, has provided the FDA with additional safety and efficacy data for its experimental therapy aimed at treating metastatic colorectal cancer. The agency respond…
    Endpoints · 3d agoRegulatoryNeutral↗ source