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602 stories matching this filter · ← front page

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  • Definium's LSD pill shows positive results in late-stage anxiety trial
    Definium Therapeutics reported that its pharmaceutical-grade LSD formulation, DT120, achieved positive outcomes in a late-stage study targeting generalized anxiety disorder. The trial used a 56-po…
    BioPharma Dive · 7h agoPositive readoutPositive↗ source
  • Boulevard Bio launches with $65 million to develop bispecific antibodies for IgA nephropathy and other autoimmune diseases
    Boulevard Bio, a new biotech co-founded by autoimmune researcher Georg Schett and former Sanofi CSO Frank Nestle, announced its launch on Wednesday with $65 million in funding. The company’s first…
    BioPharma Dive · 11h agoDealPositive↗ source
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Psychiatry & CNS670
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Infectious Disease314
  • Eli Lilly sues to curb black-market sales of experimental obesity drug retatrutide
    Eli Lilly announced it has filed six new lawsuits aimed at stopping black-market sales of its experimental obesity medicine retatrutide. The legal actions target online merchants, clinics, compound…
    BioPharma Dive · 6h agoRegulatoryNegative↗ source
  • Silence cashes in on ‘differentiated’ data; UK reaffirms support for childhood vaccines
    Some analysts believe Silence’s polycythemia vera drug could be superior to a closely watched Takeda medicine. Elsewhere, the FDA spurned a radiopharmaceutical and AbCellera shares climbed to level…
    BioPharma Dive · 9h ago↗ source
  • Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing ICU Medical Pain Management Components
    Medline is correcting affected convenience kits by removing included ICU Medical pain management components containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP.
    fda medwatch · 18h ago↗ source
  • Update on Alert: Convenience Kit Issue from Medline
    Certain BD ChloraPrep Applicators in Convenience Kits manufactured by Medline may not be sterile.
    fda medwatch · 18h ago↗ source
  • Epicrispr raises $90 million to push epigenetic editing drug EPI-321 for rare muscle disorder FSHD
    Epicrispr Biotechnologies announced a $90 million Series C financing to accelerate development of its epigenetic editing therapy EPI-321 for facioscapulohumeral muscular dystrophy (FSHD), a rare ge…
    BioPharma Dive · 1d agoDealPositive↗ source
  • Infinimmune secures $75 million Series A to develop longer-lasting eczema antibody therapies
    Infinimmune, a biotech based in Alameda, California, announced on Tuesday that it has closed a $75 million Series A financing round. The capital will support the development of its first two clinic…
    BioPharma Dive · 1d agoDealPositive↗ source
  • Trump signs executive order to split MMR vaccine and reduce U.S. childhood immunization schedule
    President Donald Trump signed an executive order on Monday that calls for a reduced U.S. childhood vaccine schedule, lowering the number of universally recommended shots from 17 to 11. The order d…
    BioPharma Dive · 1d agoRegulatoryNegative↗ source
  • Hamilton Medical issues recall of coaxial breathing circuit sets for C1, T-1 and MR1 ventilators
    Hamilton Medical has recalled specific coaxial breathing circuit sets used with its C1, T-1 and MR1 ventilators after the FDA classified the issue as a Class I recall, the most serious level, due t…
    fda medwatch · 1d agoCRLNegative↗ source
  • Former Legend Biotech CEO Ying Huang appointed head of K2 Therapeutics as startup secures $50M seed funding
    Ying Huang, who led Legend Biotech for seven years and helped develop a top‑selling cell therapy for multiple myeloma, has been named chief executive of K2 Therapeutics. The young company, founded…
    BioPharma Dive · 1d agoDealPositive↗ source
  • Vaderis raises $152 million to launch late-stage trials of AKT inhibitor engasertib for rare bleeding disorder
    Vaderis Therapeutics announced a $152 million Series B financing round, giving it sufficient capital to advance its experimental AKT-targeting drug, engasertib. The company has also begun late-sta…
    BioPharma Dive · 1d agoDealPositive↗ source
  • FDA rejects ITM radiopharma therapy while WHO defends immunization schedules
    The U.S. Food and Drug Administration has issued a rejection of a radiopharmaceutical therapy identified as ITM, indicating that the product did not meet the agency's requirements for approval. Th…
    raps · 1d agoRegulatoryNeutral↗ source
  • PIC/S releases revised guide on qualification and validation studies for pharma manufacturing
    PIC/S has issued an updated guideline that outlines general principles for qualification and validation studies in pharmaceutical manufacturing facilities. The new guide is intended for both inspe…
    raps · 1d agoRegulatoryNeutral↗ source
  • Drug makers and animal testing groups urge FDA to keep flexible guidance on animal studies for cancer drugs
    A coalition of drug developers, regulators and laboratory animal-testing organizations has asked the U.S. Food and Drug Administration to keep its guidance on cancer-drug safety studies flexible.…
    raps · 1d agoRegulatoryNeutral↗ source
  • Scribe Therapeutics launches first gene‑editing IPO in over two years, targeting high‑cholesterol gene
    Scribe Therapeutics, a gene‑editing biotech based in California, announced its initial public offering, the first for a CRISPR‑focused company in more than two years. The company, founded by resea…
    BioPharma Dive · 2d agoDealPositive↗ source
  • Jazz Pharmaceuticals to acquire Actio Biosciences in deal worth over $1.3 billion
    Jazz Pharmaceuticals announced an agreement to purchase Actio Biosciences, a San Diego biotech focused on genetic epilepsies. The transaction could total just over $1.3 billion, with $820 million…
    BioPharma Dive · 2d agoDealPositive↗ source
  • BMS to build $2.3 B Houston plant as MHRA clears Lilly's weight-loss drug; IMDRF issues PCCP guidance
    Bristol Myers Squibb announced a plan to invest about $2.3 billion in a new manufacturing facility in Houston. The site is expected to expand the company’s production capacity for its pipeline and…
    raps · 2d agoRegulatoryNeutral↗ source
  • Sionna’s cystic fibrosis candidate misses primary endpoint in Phase 2 trial, shares plunge
    Sionna Therapeutics announced that its experimental cystic fibrosis drug SION-719 failed to meet the primary endpoint in a Phase 2 trial that added the drug to Vertex Pharmaceuticals' Trikafta. Th…
    BioPharma Dive · 2d agoNegative readoutNegative↗ source
  • Abiomed and Oscor advise correction of Impella catheter introducers due to leakage risk
    Abiomed and its partner Oscor have issued a notice about a potential leakage in certain catheter introducer sheaths used with Impella heart pumps. The issue involves 14Fr and 23Fr introducer kits,…
    fda medwatch · 2d agoCRLNeutral↗ source
  • FDA issues warning letters to Indian OTC drugmaker over falsified logbooks and cites GMP lapses at two other firms
    The FDA sent warning letters to an over‑the‑counter drug manufacturer in India after discovering the company had submitted falsified production logbooks. The agency also cited two additional OTC m…
    raps · 2d agoRegulatoryNegative↗ source
  • FDA issues warning letters to Indian OTC drugmaker for falsified logbooks and to two others for GMP testing lapses
    The U.S. Food and Drug Administration sent a warning letter to an over‑the‑counter drugmaker in India after discovering that the company had submitted falsified logbooks to the agency. In addition…
    raps · 2d agoRegulatoryNegative↗ source
  • Early regulatory operations planning key to submission-ready dossiers
    Regulatory operations are often treated as a final step after all scientific data are compiled, but the article argues they should be integrated from the start of a development program. A dossier…
    BioPharma Dive · 2d agoRegulatoryPositive↗ source
  • India tightens penalties for submitting false regulatory documents
    The Indian government has introduced stricter penalties for applicants who submit misleading, fake, or fabricated documents to regulatory authorities, prohibiting them from making further filing re…
    raps · 2d agoRegulatoryNeutral↗ source
  • Aspo Oyj announces upcoming leadership changes scheduled for August 10, 2026
    Aspo Oyj, a Finnish specialty chemicals company, issued a brief notice indicating that it will implement leadership transactions. The announcement specifies that the changes will take effect on Au…
    globenewswire health · 2d agoNeutral↗ source