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  • 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 · 1d agoRegulatoryNegative↗ source
  • Novartis shareholder urges board overhaul after share plunge tied to trial setbacks
    A prominent Novartis investor has publicly called for a revamp of the company’s board, arguing that stronger governance is needed after the stock experienced a record decline. The demand was voice…
    STAT · 1d agoNegative↗ source
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  • 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 · 1d 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 · 15h 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 · 17h agoPositive↗ source
  • Two promising heart drugs fail, podcast examines why
    The latest episode of The Readout LOUD looked at two experimental therapies that had been billed as the next breakthrough in treating heart disease. The discussion highlighted how billions of dolla…
    STAT · 22h agoNegative readoutNegative↗ 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 · 1d 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 · 1d 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 · 1d agoRegulatoryNegative↗ source
  • FDA expands approval for Bayer's lung cancer therapy
    The U.S. Food and Drug Administration announced an expansion of the approved use of Bayer's lung cancer drug. The decision broadens the patient population eligible for the treatment, reflecting th…
    STAT · 1d agoApprovalPositive↗ source
  • Drugmakers Rethink Launch Strategies as MFN Pricing Rules Shake Market
    A new Numerof & Associates report says that the rollout of Most Favored Nation (MFN) pricing rules is forcing drugmakers to overhaul how they choose launch markets. Executives surveyed said the Un…
    BioSpace · 1d 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 · 1d agoNegative↗ source
  • Roivant's mosliciguat shows strong efficacy in Phase 2 PH-ILD trial
    Roivant's experimental drug mosliciguat achieved strong efficacy signals in a Phase 2 study of pulmonary hypertension associated with interstitial lung disease (PH-ILD). The mid-stage trial met its…
    STAT · 1d agoPositive readoutPositive↗ 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 · 1d agoRegulatoryNegative↗ source
  • Takeda R&D chief Andy Plump to retire after string of recent FDA approvals
    Takeda's long-serving research and development president Andy Plump will step down in June. He joined the Japanese drugmaker in 2015 from Sanofi and has led the R&D organization since then. His ex…
    Fierce Biotech · 1d agoPositive↗ source
  • Midterm races in Iowa, Florida and others could shape US vaccine policy
    Vaccine policy has emerged as a prominent issue in the lead‑up to the November midterms, spurred by the president and health secretary’s skeptical stance. In Iowa, the Republican candidate for gov…
    STAT · 1d agoNeutral↗ source
  • Pharma investment in UK rises as government increases drug pricing and engagement
    The UK trade group says pharmaceutical investment is picking up after a lull last year. The uptick follows recent government steps to raise reimbursement rates for medicines and to foster closer c…
    Endpoints · 1d agoRegulatoryPositive↗ source
  • FDA proposes 50% fee cut for US early-stage trials, but industry says speed matters more
    The FDA announced a proposal to cut the application fee by half for drugs that run their early-stage trials in the United States. The reduction, about $2.3 million at current rates, is intended to…
    BioSpace · 1d agoRegulatoryNegative↗ source
  • UK issues AI-in-medicine regulatory recommendations; FDA pauses new enrollment in Biohaven epilepsy trials
    The United Kingdom has released a set of recommendations aimed at governing the use of artificial intelligence in medical applications. The guidance outlines how AI tools should be evaluated and mo…
    raps · 1d agoRegulatoryNeutral↗ source
  • Trump administration to mail $500 checks to about 1 million non‑subsidized ACA enrollees before midterms
    The White House announced a program to send $500 refund checks to roughly one million people who have Affordable Care Act health plans but do not receive federal subsidies. The payments are schedul…
    STAT · 19h agoNegative↗ source
  • Takeda R&D chief Andy Plump to retire in June 2027 after 12-year tenure
    Takeda announced that its longstanding head of research and development, Andy Plump, will step down and retire in June 2027. Plump has been with the Japanese drugmaker for about 12 years, leading…
    BioSpace · 21h agoNeutral↗ source
  • Study finds doctors still accept pharma gifts and speaking fees despite ongoing debate
    A new analysis surveyed 283 physicians who had previously responded as part of a 2011 study of more than 1,300 medical students and residents. The researchers compared the recent responses with the…
    STAT · 22h agoNegative↗ source
  • Lonza announces new spray-drying plant in Bend, Oregon as Samsung Bio secures $262 million contract
    Lonza announced plans to construct a new commercial spray-drying facility in Bend, Oregon, expanding its manufacturing footprint in the United States. The plant will increase Lonza’s capacity to p…
    Endpoints · 1d agoPositive↗ source
  • Tyra Biosciences shares tumble as bladder cancer pill shows lower-than-expected complete response
    Tyra Biosciences presented Phase 2 SURF302 data for its investigational oral drug dabogratinib in patients with low‑grade intermediate‑risk non‑muscle invasive bladder cancer. The trial reported th…
    BioSpace · 1d agoNegative readoutNegative↗ 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 · 1d agoPositive readoutNeutral↗ source