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977 stories matching this filter · ← front page

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  • FDA issues warning letters to Bausch & Lomb and Indian API maker over GMP lapses
    The U.S. Food and Drug Administration sent warning letters to two companies after finding violations of good manufacturing practice. Bausch & Lomb, which produces ophthalmic products, was cited f…
    raps · 1mo agoRegulatoryNegative↗ source
  • Experts review five decades of regulatory evolution at RAPS Convergence 2026
    At the opening plenary of RAPS Convergence 2026 in Charlotte, NC, specialists in medical device and pharmaceutical regulatory affairs gathered to discuss the field’s trajectory. They reflected on…
    raps · 1mo agoRegulatoryNeutral↗ source
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fda medwatch109
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  • Summit and Akeso report ivonescimab extends lung cancer survival by eight months versus Keytruda in Phase 3 trial
    Summit Therapeutics and its partner Akeso said their experimental dual-target drug ivonescimab added about eight months of overall survival for patients with lung cancer compared with Merck's Keytr…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • AstraZeneca’s newly approved pill fails frontline breast cancer study
    Etcamah is the second oral “SERD” to recently fall short in first-line breast cancer, following a similar setback from Roche earlier this year.
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • FDA approves Scholar Rock's muscle-targeted SMA therapy Isembyld
    The Food and Drug Administration has approved a new medication for spinal muscular atrophy (SMA). The drug, apitegromab marketed as Isembyld, is the first muscle-targeted therapy for the disease.…
    BioPharma Dive · 1mo agoApprovalPositive↗ source
  • Cellectis abandons CAR-T programs, shifts focus to in vivo gene editing
    Cellectis announced it will discontinue its donor-derived CAR‑T programs and redirect its efforts toward in vivo gene‑editing medicines. The company said the commercial and clinical landscape for…
    BioPharma Dive · 1mo agoNegative↗ source
  • FDA appoints new oncology chief, pledges ongoing innovation; approves treatments for two rare genetic disorders
    The Food and Drug Administration has announced a new leader for its Oncology Center of Excellence. The appointee emphasized a continued focus on innovative cancer therapies and collaborative resear…
    raps · 1mo agoRegulatoryPositive↗ source
  • Singapore moves forward with legislation for a more coherent, future-ready healthcare regulatory system
    Singapore's Parliament has taken a step toward overhauling its healthcare regulatory framework by advancing new legislation. The proposed law aims to create a more coherent and future-ready system…
    raps · 1mo agoRegulatoryPositive↗ source
  • EMA says regulators pledge API inspection sharing but report modest progress
    The European Medicines Agency reports that regulators worldwide are strongly committed to sharing plans for good manufacturing practice inspections of active pharmaceutical ingredient suppliers. D…
    raps · 1mo agoRegulatoryNeutral↗ source
  • RAPS Convergence 2026 Highlights Future of Regulatory Science and Patient Safety
    The RAPS Convergence 2026 event gathered regulatory professionals to reflect on how the field has changed. Attendees discussed how emerging technologies are reshaping regulatory processes and expe…
    raps · 1mo agoRegulatoryPositive↗ source
  • EMA issues new guideline on assessing gastrointestinal drug interaction risks
    The European Medicines Agency has released a guideline that outlines how to evaluate drug interactions that occur in the gastrointestinal (GI) tract. The document focuses on extrinsic factors such…
    raps · 1mo agoRegulatoryNeutral↗ source
  • RA Capital backs four biotech rounds in September as Novartis shares tumble after trial setbacks
    RA Capital Management participated in four biotech financings in September, including Series A rounds for Solstice Oncology and Tectora Therapeutics, as well as co-leading a $56 million round for T…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Karyopharm Secures One-Month Debt Extension While Awaiting Xpovio Decision
    Karyopharm Therapeutics, facing cash constraints, has negotiated a temporary reprieve on a $15.8 million debt that was due. Under the agreement, lenders and noteholders will refrain from enforceme…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • mRNA cancer vaccines’ biggest barriers to market
    Manufacturing hurdles are just one challenge the industry must overcome to commercialize personalized mRNA cancer vaccines.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ 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 · 2mo agoRegulatoryNeutral↗ 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 · 2mo agoRegulatoryNegative↗ source
  • Reverse mergers surge as biotech firms seek public listings via shell companies
    Reverse mergers, once dismissed, are now a common route for biotech startups to gain a public listing by merging with shell companies. Data from JB Strategy Partners shows roughly two dozen such d…
    BioPharma Dive · 2mo agoDealNegative↗ 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 · 2mo agoRegulatoryNeutral↗ 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 · 2mo agoNeutral↗ 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 · 2mo agoRegulatoryNeutral↗ 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 · 2mo agoRegulatoryNeutral↗ source
  • Solstice Oncology secures $225M Series A to advance CTLA-4 antibody porustobart in colon cancer
    Solstice Oncology, a biotech startup focused on immunotherapy, announced it has raised $225 million in a Series A financing round. The funding will support development of its lead candidate, a CTL…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Tyra Biosciences’ bladder cancer pill misses expected response rate in Phase 2 trial
    Shares of Tyra Biosciences dropped about 20% after data from its Phase 2 study of a bladder cancer pill fell short of market expectations. The experimental drug, dabogratinib, is taken daily and t…
    BioPharma Dive · 2mo agoNegative readoutNegative↗ source
  • Kura Oncology launches Caspian Therapeutics to develop menin-inhibitor diabetes drug with $50M funding
    Kura Oncology has spun out a new biotech called Caspian Therapeutics to focus on menin inhibitors for diabetes and other cardiometabolic diseases. The company’s lead candidate, code-named KO-7246,…
    BioPharma Dive · 2mo 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 · 2mo agoRegulatoryPositive↗ source