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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 · 3d agoRegulatoryNegative↗ 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
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fda recalls71
fda medwatch63
fda press38
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Psychiatry & CNS895
Ophthalmology521
Pain503
Endocrinology & Metabolism496
Infectious Disease459
  • 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
  • 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 · 3d agoRegulatoryNegative↗ 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
  • 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 · 4d agoPositive↗ 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 · 4d 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 · 4d agoRegulatoryNeutral↗ 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 · 3d agoNeutral↗ 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 · 3d agoNegative readoutNegative↗ source
  • August 2026 biopharma layoffs affect just over 500 workers, a 90% drop from a year earlier
    In August 2026, twelve biotech and pharmaceutical firms announced workforce reductions, impacting a total of about 526 employees. This represents a sharp 90% decline in the number of people affecte…
    BioSpace · 4d agoLayoffsNegative↗ source
  • FDA signals openness to innovative approaches for psychedelic drug development
    FDA officials said the agency is open to novel, innovative approaches to the clinical development of psychedelic drugs, citing the worsening mental health crisis in the United States. The agency’s…
    raps · 4d agoRegulatoryNeutral↗ source
  • Scientists boycott American Diabetes Association after conference expulsions
    Following the removal of five scientists from its annual conference in June, members of the American Diabetes Association (ADA) have initiated a boycott of the organization. The protest stems from…
    Fierce Biotech · 3d agoNegative↗ source
  • EMA revises GVP inspection guideline to incorporate new subcontractor rules
    The European Medicines Agency has issued an update to its guideline on good pharmacovigilance practice inspections. The revision aligns the guidance with recent changes to the rules governing subco…
    raps · 4d agoRegulatoryNeutral↗ source
  • Takeda R&D chief Andy Plump to leave after 12 years
    Takeda announced that its President of Research and Development, Andy Plump, M.D., Ph.D., will depart the company in June after serving in the role for twelve years. He will remain in charge of R&D…
    Fierce Biotech · 3d agoNeutral↗ source
  • CDMOs Redefine Pharma Supply Chains with AI, Cold-Chain Logistics and Smart Sourcing
    In a recent episode of BioSpace’s Denatured podcast, host Jennifer Smith-Parker talks with Arvind Singh, vice-president and global head of supply chain at SK Pharmteco. The discussion is presented…
    BioSpace · 4d agoNeutral↗ source
  • AI transforms talent strategy in life-science companies, moving from tools to strategic intelligence
    Applying artificial intelligence and automation has moved from experimental use to a core topic in talent strategy discussions across life‑science firms. Early efforts focused on testing tools and…
    BioSpace · 4d agoPositive↗ source
  • BioSpace reports 11 California biopharma firms posting over 400 jobs as openings rise 31% YoY
    BioSpace's latest job trend data shows a sharp increase in biopharma openings in California, with postings up 31% year-over-year in August. More than 400 positions are currently listed, reflecting…
    BioSpace · 4d agoNeutral↗ source
  • Medical Action Industries issues correction for epidural kits containing recalled Huons Co. lidocaine ampules
    Medical Action Industries has released a correction notice for several of its epidural kit products after discovering that they contain lidocaine ampules from Huons Co. that were previously recalle…
    fda medwatch · 4d agoCRLNeutral↗ 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 · 4d agoNegative↗ source
  • Evommune gives up hope for MRGPRX2 antagonist to treat itch after latest phase 2 fail
    Evommune’s MRGPRX2 antagonist has flunked another phase 2 trial, wiping out the biotech’s last hopes of developing the therapy for any itch-related conditions.
    Fierce Biotech · 5d agoNegative readoutNegative↗ source
  • Sandoz to invest $1 billion in European biosimilar hub, targeting 100 biosimilars by 2040
    Sandoz announced at its investor day that it will spend roughly $1 billion to build a fully integrated European biosimilar hub as part of a plan to bring more than 100 biosimilars to market by 2040…
    BioSpace · 4d agoPositive↗ source
  • Solstice Oncology secures $225M Series A to launch FDA-cleared Phase 2 CTLA-4 antibody trial
    Solstice Oncology, a cancer-focused startup that emerged from stealth in February, announced a $225 million Series A financing round to fund its early-stage programs. The capital will be used to a…
    BioSpace · 5d agoDealPositive↗ source
  • Luma Group closes $410 million, 15-year life-science venture fund
    Luma Group announced that its first life‑science venture capital fund has reached final close, raising $410 million for a 15‑year investment period. The New York‑based firm said the capital will be…
    Fierce Biotech · 5d agoDealPositive↗ source