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  • Roche, MediLink notch phase 3 lung cancer win but trail GSK on cross-trial survival
    MediLink has reported phase 3 results on a Roche-partnered antibody-drug conjugate. The small-cell lung cancer trial hit its primary endpoint, although the B7-H3-directed ADC’s median overall survi…
    Fierce Biotech · 4h ago↗ 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 · 1d agoPositive readoutPositive↗ source
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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 · 1d 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 · 2d 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 · 2d 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 · 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 · 3d 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 · 2d 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 · 2d agoNegative↗ 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 · 2d 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 · 3d 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 · 2d agoDealNeutral↗ 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 · 3d 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 · 2d agoRegulatoryNeutral↗ source
  • BioNTech sets survival standard in hard-to-treat cancer ahead of pivotal readout
    BioNTech has linked gotistobart to median overall survival of 18.5 months in relapsed lung cancer patients, adding to evidence that the anti-CTLA-4 antibody is better than the standard of care.
    Fierce Biotech · 3d ago↗ source
  • Novartis shareholder urges board overhaul after costly Avidity acquisition setbacks
    Novartis investor David Samra, managing director at Artisan Partners, told Reuters that the company’s board should be reshaped to improve oversight of its dealmaking activities. He said the board n…
    Fierce Biotech · 4d agoDealNegative↗ source
  • FDA signals openness to innovative trial designs for psychedelic therapies
    FDA regulators said they are willing to consider more flexible approaches for evaluating psychedelic medicines. The agency noted that studies could use active comparators instead of placebo, which…
    Endpoints · 3d agoRegulatoryPositive↗ source
  • Frazier Life Sciences raises over $1.1 billion for its public biotech fund, now $2.8 billion total
    Frazier Life Sciences announced that its public fund has secured more than $1.1 billion in new capital, bringing the fund’s total assets to $2.8 billion. The fund, launched in 2021, targets small-…
    Fierce Biotech · 4d agoDealPositive↗ source
  • New FDA Oncology Center chief Angelo de Claro pledges AI integration and trial expansion
    Angelo de Claro, M.D., has taken over as the permanent head of the FDA’s Oncology Center of Excellence after serving as acting director since late 2025. In his first interview, he said the agency w…
    Fierce Biotech · 3d agoRegulatoryNeutral↗ source
  • Singapore opens biotech-focused Boston hub, strengthening ties with city
    Singapore announced the opening of its fifth U.S. overseas centre, a biotech-focused hub in Boston, during an event at the historic Raffles Hotel. Government officials and business leaders gathered…
    Fierce Biotech · 3d agoPositive↗ source
  • Shionogi's mid-stage stroke drug redasemtide fails, while Bayer's Hyrnuo receives expanded NSCLC label
    Shionogi reported that its experimental stroke therapy redasemtide did not achieve the primary endpoint in a mid-stage clinical trial, marking a setback for the company’s neurology pipeline. The f…
    Endpoints · 3d agoNegative readoutNeutral↗ source
  • ARPA-H launches ADVOCATE program to fund AI agents for health tech companies
    ARPA-H, the federal agency that funds breakthrough health technologies, announced the start of a new initiative called ADVOCATE. The program will award millions of dollars in grants to health-tech…
    Endpoints · 3d agoPositive↗ source
  • FDA imposes partial clinical hold on Biohaven's experimental epilepsy drug BHV-7000
    FDA announced a partial clinical hold on Biohaven's ion channel program, affecting the epilepsy trial of the experimental drug BHV-7000. The hold was issued after the agency requested additional p…
    Endpoints · 3d agoRegulatoryNegative↗ source
  • BridgeBio Oncology shares tumble 24% as it narrows KRAS program focus
    BridgeBio Oncology Therapeutics saw its stock drop sharply after announcing a strategic shift. The company said it will scale back its broader pipeline to concentrate resources on its lead KRAS in…
    Endpoints · 3d agoNegative↗ source
  • FDA places partial hold on Biohaven epilepsy drug BHV-7000 amid $350 million licensing deal
    The U.S. Food and Drug Administration issued a partial clinical hold on enrollment for Biohaven’s epilepsy candidate BHV-7000 after rodent studies raised questions about drug metabolites. The hold…
    Fierce Biotech · 4d agoRegulatoryNegative↗ source