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  • Funding shortfall threatens progress of new Ebola vaccine candidates
    A rapidly expanding Ebola outbreak in Africa has spurred multiple groups to accelerate vaccine development. The effort is being coordinated by a key global health organization, but the group is fa…
    Endpoints · 8d agoNegative↗ source
  • Ionis secures FDA approval for zilganersen, its first solo neurology therapy for Alexander disease
    Ionis Pharmaceuticals announced that the U.S. Food and Drug Administration has granted approval to its investigational RNA‑based drug zilganersen for the treatment of Alexander disease, a rare neur…
    Endpoints · 8d agoApprovalPositive↗ source
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  • FDA issues guidance to prevent newborn nutrition supply gap
    The U.S. Food and Drug Administration announced it is taking action to address a potential supply gap of neonatal starter parenteral nutrition, which provides essential IV nutrients to premature an…
    fda press · 8d agoRegulatoryPositive↗ source
  • NeuShen Therapeutics raises over $80 million to advance three brain-health drug candidates
    NeuShen Therapeutics, a biotech with operations in Shanghai and Boston, announced it has closed a Series B financing round of more than $80 million. The capital will be used to move three clinical…
    Endpoints · 8d agoDealPositive↗ source
  • Menarini secures European rights to Chinese GLP-1 obesity drug
    Menarini Group, a large family‑owned pharmaceutical company in Italy, has obtained the European commercial rights to a GLP‑1 agonist developed by China’s Gan & Lee. The agreement gives Menarini a…
    Endpoints · 8d agoDealPositive↗ source
  • Thiel-backed Lindus Therapeutics sells CRO division and shifts focus to acquiring drug assets
    Lindus Therapeutics, a transatlantic startup backed by Peter Thiel, announced the sale of its contract research organization (CRO) arm. The company, previously positioning itself as an “anti‑CRO,”…
    Endpoints · 8d agoDealNeutral↗ source
  • FDA approves Zanvastro, first therapy targeting protein buildup in Alexander disease
    The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in both pediatric and adult patients. Zanvastro is the first FDA-approve…
    fda press · 9d agoApprovalPositive↗ source
  • Akeso and Summit report ivonescimab meets overall survival endpoint in Phase 3 lung cancer trial
    Akeso and its partner Summit said the Phase 3 trial of ivonescimab, a PD-1xVEGF bispecific antibody, has met its overall survival endpoint in a selected group of lung cancer patients. The announcem…
    Endpoints · 9d agoPositive readoutPositive↗ source
  • AbbVie reports 60% reduction in progression risk for myeloma drug etentamig in Phase 3 trial
    AbbVie announced results from a Phase 3 study of its T cell engager etentamig in patients with multiple myeloma. The trial demonstrated a 60% relative reduction in the risk of disease progression…
    Endpoints · 9d agoPositive readoutPositive↗ source
  • GSK licenses Hutchmed's KRAS-EGFR antibody-drug conjugate for $110 million upfront
    GSK announced it will pay $110 million upfront to obtain a license for a KRAS-EGFR antibody-drug conjugate developed by Chinese biopharma Hutchmed. The agreement also includes potential milestone p…
    Endpoints · 9d agoDealPositive↗ source
  • Merck's dealmaker warns of increased M&A activity as Keytruda patent expires
    Merck's chief M&A officer says the company expects a surge in deal flow as the patent for its flagship immunotherapy, Keytruda, approaches expiration. The leadership has been pursuing acquisitions…
    Endpoints · 9d agoDealNeutral↗ source
  • Health tech investors shift focus to larger funding rounds, Cityblock secures $116 million
    Throughout the past year, investors in digital health have increasingly favored megafunding rounds rather than smaller seed or Series A deals. In August, community-health startup Cityblock announc…
    Endpoints · 9d agoDealPositive↗ source
  • FDA requests public input to accelerate botanical drug product development
    The U.S. Food and Drug Administration issued a request for information (RFI) to collect public comments on ways to move botanical drug products forward. Botanical drug products are derived from pl…
    fda press · 9d agoRegulatoryNeutral↗ source
  • Superluminal Medicines raises $60M Series B to launch Phase 1 trial of genetic obesity therapy
    Superluminal Medicines, a Boston‑based biotech, announced it has closed a $60 million Series B financing round. The capital will fund the company’s first‑in‑human study of its genetic obesity candi…
    Endpoints · 9d agoDealNeutral↗ source
  • Ultragenyx's Angelman syndrome drug fails Phase 3 trial, halting development
    Ultragenyx reported that its experimental antisense oligonucleotide designed for Angelman syndrome did not meet primary endpoints in a Phase 3 study. The trial, which enrolled patients with the ra…
    Endpoints · 9d agoNegative readoutNegative↗ source
  • FDA grants emergency use authorization for Capstar and generic nitenpyram to prevent and treat New World screwworm in dogs and cats
    The U.S. Food and Drug Administration issued an Emergency Use Authorization for Capstar (nitenpyram) tablets and updated the EUA for the generic Nitenpyram Tablets. Both products are now authorized…
    fda press · 9d agoRegulatoryPositive↗ source
  • Pfizer grants Medicus co-development rights to CD228-targeted ADC PF-08046031
    Pfizer announced it is transferring co-development rights for its CD228-targeted antibody-drug conjugate, PF-08046031, to Medicus Pharma. The ADC, originally discovered by Seagen, will now be adva…
    Endpoints · 9d agoDealNeutral↗ source
  • Novartis licenses Alteogen’s hyaluronidase enzyme ALT-B4 in new drug delivery partnership
    Novartis announced a licensing agreement with South Korean biotech Alteogen to use its hyaluronidase enzyme ALT-B4 for drug delivery applications. The enzyme will be produced using Alteogen’s prop…
    Endpoints · 9d agoDealNeutral↗ source
  • Deaths of two Chinese children receiving CRISPR therapy spark safety debate
    Two children in China died after receiving experimental CRISPR-based gene therapies, according to a recent report. The fatalities have unsettled researchers in the United States who are developing…
    Endpoints · 10d agoRegulatoryNegative↗ source
  • Novartis CAR-T trial deaths spark safety concerns for autoimmune applications
    Novartis disclosed that three participants in its CAR-T cell therapy trials for autoimmune disease have died. The company said the deaths were reported to health authorities and are under investiga…
    Endpoints · 10d agoRegulatoryNegative↗ source
  • FDA CBER director overrides review team to grant accelerated approval for Replimune's melanoma therapy Tudriqev
    A senior official at the FDA's Center for Biologics Evaluation and Research stepped in to reverse a prior rejection by the agency's review panel. The director of the office of clinical evaluation a…
    Endpoints · 10d agoApprovalPositive↗ source
  • FDA vows tighter review of foreign clinical trial data amid rising Chinese influence
    Top FDA officials announced that the agency will intensify its oversight of clinical trial data generated outside the United States. The move is aimed at ensuring that foreign data meet the same st…
    Endpoints · 10d agoRegulatoryNeutral↗ source
  • UK regulator suspends Tavneos sales as MHRA follows EMA decision; UniQure files for Huntington's gene therapy approval
    The UK Medicines and Healthcare products Regulatory Agency has ordered a halt to the sale of the drug Tavneos, citing concerns that align with a recent decision by the European Medicines Agency. T…
    Endpoints · 10d agoRegulatoryNegative↗ source
  • Teva's experimental antibody cuts intestinal damage in celiac patients after gluten challenge
    Teva reported that a single injection of an experimental antibody markedly lowered intestinal damage in participants with celiac disease who continued to consume gluten daily. The study was a glut…
    Endpoints · 10d agoPositive readoutPositive↗ source
  • Typewriter secures $56M to advance jumping-gene platform and in vivo CAR-T therapies
    Typewriter, a biotech startup, announced it has closed a $56 million financing round. The capital will be used to develop its jumping-gene platform, which seeks to deliver full genes without viral…
    Endpoints · 10d agoDealPositive↗ source