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Regulatory Intelligence & Drug Approvals2 weeks agoFDA grants accelerated approval to dostarlimab for locally advanced rectal cancer
Oncology Burst: FDA grants accelerated approval to dostarlimab for locally advanced rectal cancer
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Regulatory Intelligence & Drug Approvals2 weeks agoNotices of Updates
Webpage providing notices of updates to FDA's STIC webpages for antibacterial and antifungal drugs.
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Regulatory Intelligence & Drug Approvals2 weeks ago2026 Meeting Materials, Pediatric Advisory Committee
Meeting announcements, agendas, briefing materials, and presentations for the 2026 meetings of the FDA's Pediatric Advisory Committee
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Regulatory Intelligence & Drug Approvals2 weeks agoDisc’s rebuffed rare disease drug sets up FDA redo after ‘clean’ Phase 3 sweep
Disc Medicine’s bitopertin—rejected by the FDA in February—significantly reduced levels of a key disease biomarker and significantly increased the time patients with erythropoietic protoporphyria were able...
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Regulatory Intelligence & Drug Approvals2 weeks agoFDA approves Viatris’ Ryzumvi for adult presbyopia
In the US, Ryzumvi is already marketed as the sole authorised treatment for pharmacologically-induced mydriasis. Under a global licensing agreement with Opus Genetics, Viatris holds exclusive...
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Regulatory Intelligence & Drug Approvals2 weeks agoFDA Approves Genentech’s Enspryng, a First-in-Class IL-6R Inhibitor, as the First and Only At-Home Subcutaneous Treatment Option for Thyroid Eye Disease (TED)
South San Francisco, CA -- October 15, 2026 -- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S....
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Regulatory Intelligence & Drug Approvals2 weeks agoStockWatch: Liquidia Rebounds After Settling Legal Wrangle with United Therapeutics
Two weeks after its stock lost more than half its value following a setback in a seven-year legal wrangle, Liquidia shares finally began bouncing back thanks...
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Regulatory Intelligence & Drug Approvals2 weeks agoNavigating the FDA Bayesian Draft Guidance: Design, Analysis, and Review Considerations – 10/14/2026
Clinical trial, regulatory science and regulatory affairs professionals working on clinical trials and studies where Bayesian approaches may be used or potentially beneficial should attend this...
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Regulatory Intelligence & Drug Approvals2 weeks agoEMA’s CHMP backs RevMed’s first-in-class pancreatic cancer therapy
BIOCENTURY | REGULATIONEMA’S CHMP BACKS REVMED’S FIRST-IN-CLASS PANCREATIC CANCER THERAPYRecommendations follow speedy FDA approvals of the RAS(ON) inhibitor and Lilly’s obesity pill Foundayo orforglipron
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Regulatory Intelligence & Drug Approvals2 weeks ago
UCB Announces U.S. FDA Approval for Zilbrysq (zilucoplan) Autoinjector Self-administration for Adults Living with Generalized Myasthenia Gravis
Brussels, Belgium and Atlanta, Georgia – October 16, 2026 – UCB (Euronext Brussels: UCB), a global biopharmaceutical company, today announced that the U.S. Food and Drug...
RNA-protein interactions could lead to new coronavirus drug targets
A CRISPR gene boost reduces seizures and strengthens muscles in mice
Automated platform optimizes enzyme production using cell-free protein synthesis and AI-driven design
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
