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596 stories matching this filter · ← front page

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  • 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 · 16h agoDealNegative↗ source
  • Encoded Therapeutics secures $275M Series F to advance gene therapy for Dravet syndrome
    Encoded Therapeutics announced a $275 million Series F financing round aimed at moving its lead gene‑therapy candidate, ETX101, toward pivotal trials for Dravet syndrome. In the ongoing Phase 1/2…
    BioSpace · 13h agoDealPositive↗ source
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Infectious Disease455
  • Study finds childhood platinum chemotherapy ages liver cells, may increase future cancer risk
    A new study published in Science examined children who received platinum‑based chemotherapy, such as cisplatin or carboplatin, followed by surgery for hepatoblastoma. Researchers collected samples…
    STAT · 8h agoNegative readoutNegative↗ source
  • FDA pauses enrollment in Biohaven's epilepsy trials after earlier depression trial failure
    FDA placed a partial clinical hold on Biohaven's Kv7 potassium channel agonist, BHV-7000 (opakalim), halting enrollment of new patients in two late-stage focal epilepsy studies. The pause follows…
    BioSpace · 12h agoRegulatoryNegative↗ source
  • FDA issues partial hold on Biohaven’s experimental epilepsy drug opakalim, pausing recruitment in late-stage trial
    Biohaven announced that the FDA has placed a partial hold on its experimental epilepsy therapy, opakalim, after the company recently transferred rights to the drug in a licensing agreement. The ag…
    BioPharma Dive · 10h agoRegulatoryNegative↗ source
  • Takeda R&D chief Andy Plump to retire in June 2027, will stay on board through 2027
    Takeda announced that Andy Plump, who has led the company's research and development since 2015, will retire in June 2027. Plump will remain president of R&D until a successor is appointed and wil…
    BioPharma Dive · 11h agoNeutral↗ source
  • UniQure to release four-year Huntington’s gene therapy results by September
    UniQure, a biotech firm, will report four-year data from its Huntington’s disease gene therapy trial before the end of September. The therapy, AMT-130, has already been submitted to regulators in…
    STAT · 16h agoPositive readoutNeutral↗ source
  • Novo Nordisk halts two IL-6 heart trials as Novartis suffers Phase 3 setbacks; Ionis wins first Alexander disease approval
    Novo Nordisk announced it has ended two late‑stage studies of its investigational IL‑6 inhibitor ziltivekimab, which was being evaluated for cardiovascular disease. The decision follows an earlier…
    BioSpace · 1d agoNegative↗ source
  • Encoded Therapeutics secures $275M Series F to push Dravet gene therapy and expand manufacturing
    Encoded Therapeutics, a biotech focused on neuro‑genetic disorders, announced a $275 million Series F financing round. The capital was co‑led by Google Ventures and an undisclosed healthcare fund,…
    Fierce Biotech · 1d agoDealPositive↗ source
  • FDA appoints permanent heads of CDER and CBER, adding AI deputy role
    The Trump administration announced permanent appointments to two key FDA centers after a period of turnover. Michael Davis, who had been acting director of the Center for Drug Evaluation and Resea…
    BioPharma Dive · 1d agoRegulatoryPositive↗ source
  • Biotech crossover rounds projected to exceed $4.2 billion in 2026, supporting IPO pipeline
    PitchBook forecasts that biotech crossover rounds could surpass $4.22 billion across roughly 28 rounds in 2026. The surge follows a market bottom after COVID and a rise in investor confidence, wit…
    BioSpace · 1d agoDealPositive↗ source
  • CLINUVEL to cut up to 20% of staff and move headquarters to New York
    CLINUVEL announced a strategic reorganization aimed at focusing resources on the U.S. market. The company will reduce its global workforce by 10% to 20%, affecting up to 21 of its 104 employees.…
    BioSpace · 1d agoLayoffsNegative↗ source
  • FDA grants accelerated approval to AstraZeneca’s Etcamah, enabling ctDNA-guided therapy for HR-positive breast cancer
    The FDA issued an accelerated approval for AstraZeneca’s oral selective estrogen receptor degrader camizestrant, to be sold as Etcamah, marking a rare departure from its advisory committee’s recomm…
    Fierce Biotech · 2d agoApprovalPositive↗ source
  • Novartis' $12 billion Avidity drug fails Phase 3 trial in myotonic dystrophy
    Novartis reported that its antibody-oligonucleotide conjugate del-desiran did not meet the primary endpoint in the Phase 3 HARBOR study for myotonic dystrophy type 1, showing no significant improve…
    BioSpace · 2d agoNegative readoutNegative↗ source
  • Roivant reports record-breaking Phase 2 results for PH-ILD drug mosliciguat, starts Phase 3
    Roivant announced that its experimental drug mosliciguat met all primary and secondary endpoints in a Phase 2 study in patients with pulmonary hypertension associated with interstitial lung disease…
    BioPharma Dive · 2d agoPositive readoutPositive↗ source
  • Roivant's experimental pulmonary hypertension drug meets Phase 2 goals
    Roivant announced that its experimental drug mosliciguat achieved the primary endpoint in a 16‑week Phase 2 trial for pulmonary hypertension, a serious lung condition. The study showed a 56% reduc…
    STAT · 2d agoPositive readoutPositive↗ source
  • Novartis' DM1 drug del-desiran misses primary endpoint in Phase 3 HARBOR trial
    Novartis announced that its experimental therapy del-desiran did not improve muscle function in a pivotal Phase 3 study for myotonic dystrophy type 1 (DM1). The trial, called HARBOR, evaluated the…
    STAT · 2d agoNegative readoutNegative↗ source
  • Structure Therapeutics reports oral GLP-1 weight-loss results comparable to Wegovy and strong Phase 1 amylin data
    Structure Therapeutics announced that its oral GLP-1 candidate aleniglipron achieved 72-week weight-loss results that BMO Capital Markets said were in line with Novo Nordisk’s oral Wegovy. Particip…
    BioSpace · 2d agoPositive readoutPositive↗ source
  • Novartis' experimental drug fails pivotal trial for rare neuromuscular disease
    Novartis reported that its experimental therapy for a rare neuromuscular disorder did not improve muscle function in a pivotal study, missing its primary endpoints. The failure represents the comp…
    STAT · 2d agoNegative readoutNegative↗ source
  • Novartis' del-desiran misses primary goal in late-stage myotonic dystrophy trial
    Novartis announced that its experimental RNA drug del-desiran did not achieve the primary endpoint in a late-stage study of myotonic dystrophy type 1, a rare muscle‑weakening disease. The trial me…
    BioPharma Dive · 2d agoNegative readoutNegative↗ source
  • BrainChild Bio secures $119M Series A to advance CAR-T therapy for deadly pediatric brain tumor
    BrainChild Bio announced a $119 million Series A financing round aimed at moving its CAR‑T programs for central nervous system cancers in children forward. The company’s lead candidate, BCB-276, w…
    BioSpace · 2d agoDealPositive↗ source
  • BrainChild secures $116M to advance CAR-T therapies for rare pediatric brain tumors
    BrainChild Bio, a Seattle‑based biotech spun out of Seattle Children’s Hospital, announced it has raised $116 million in venture financing. The capital will fund the development of its CAR‑T cell t…
    BioPharma Dive · 2d agoDealPositive↗ source
  • Rural hospitals seek partnership deals as Trump Medicaid cuts threaten financial stability
    Rural health systems are looking for mergers or partnership agreements to stay afloat as the Trump administration prepares unprecedented cuts to Medicaid funding. The anticipated reductions are pr…
    STAT · 2d agoDealNegative↗ source
  • Inhibrx reports promising responses to OX40 immunotherapy in HPV-positive head and neck cancer
    Inhibrx announced that its experimental immunotherapy targeting the protein OX40 produced measurable responses in patients with head and neck cancer, with the clearest activity observed in a small…
    STAT · 2d agoPositive readoutPositive↗ source
  • Pharvaris reports 83% drop in hereditary angioedema attacks in phase 3 trial, FDA decision pending
    Pharvaris announced that its oral bradykinin B2 receptor antagonist, deucrictibant, met the primary goal in a second phase 3 study. The trial, called CHAPTER-3, enrolled 85 patients with three for…
    Fierce Biotech · 2d agoPositive readoutPositive↗ source