Helixgate https://validator.w3.org/feed/docs/rss2.html FDA could approve psychedelics before redosing is resolved Suppressor tRNAs take two translational steps forward Psychedelics at FDA, Mike Davis’ CDER and translating tRNAs — a BioCentury podcast   STAT+: Pharmalittle: We’re reading about another AstraZeneca trial failure, a Novo name change, and more Scholar Rock secures first FDA approval for muscle-targeting rare disease drug Blood centers can help biopharma scale cell and gene therapies Cyclic peptides open new drug frontiers, if manufacturing can keep up AstraZeneca’s newly approved cancer pill fails late-stage study, blocking path to bigger market Definium moves toward FDA submission for LSD drug in anxiety after ‘another clear win’ Summit, BioNTech, more headline WCLC with next-gen lung cancer drugs Novo Nordisk rebrands as Novo as new CEO charts turnaround Scholar Rock gets first drug approval as FDA okays Isembyld Resistance grows to Recordati’s private equity takeover AZ’s Etcamah falls short in first-line breast cancer trial FDA Approves Omcazio (cabozantinib) Capsule Formulation for Administration Without Regard to Food FDA Approves Isembyld (apitegromab-mstn) Muscle-Targeted Treatment for Children and Adults with Spinal Muscular Atrophy (SMA) Why Does a Particular Genetic Variant Lead to Accelerated Huntington Disease Development? StockWatch: Novartis Loses More than Market Value After Phase III Failure Evonik Expands in Slovakia With pharmaceutical tariffs looming, guidance on compliance is still lacking RISE to the Challenge: Statistical Considerations for Rare Disease Clinical Investigations – 09/29/2026 List of Determinations Including Written Request Public Meeting on the Recommendations for Reauthorization of the Prescription Drug User Fee Act (PDUFA) – 09/16/2026 2026 DIA/FDA Oligonucleotide-Based Therapeutics Conference – 09/23/2026 How is API Manufacturing Changing? Scholar Rock scores long-awaited FDA approval, the first for muscle loss in SMA GSK makes ‘difficult decision’ to shutter German flu vaccine manufacturing site No more Nordisk as Novo goes it alone amid rebranding push STAT+: Definium’s LSD therapy eased anxiety in second large trial Cullinan, Taiho showcase 6-month survival benefit in phase 3 trial for advanced lung cancer BioNTech sets survival standard in hard-to-treat cancer ahead of pivotal readout Corbus posts phase 1 obesity data for drug mechanism that defeated Novo, Sanofi Electra aims for $342M IPO to power inflammatory drug’s push through phase 3 Cellectis cans allogeneic CAR-Ts to hop aboard in vivo bandwagon Roche, MediLink notch phase 3 lung cancer win but trail GSK on cross-trial survival Definium LSD drug goes 3 for 3 with another pivotal anxiety trial win Considerations for Potential Future Therapeutic Use of Psychedelic Drugs Public Hearing – 09/14/2026 FDA Rare Disease Innovation Hub STAT+: Scholar Rock wins FDA approval for first drug to target SMA muscle loss Novel Drug Approvals for 2026 What’s New Related to Drugs Drugs@FDA Data Files AI automates 3D membrane mapping, matching manual results in a fraction of time STAT+: Trump’s secretive pharma deals may undermine ‘most-favored nation’ pricing, an analysis suggests After a brief storm of political headwinds, mRNA is back with strong momentum Psychedelic therapies ride wave of public favor into FDA hearing Centric Compounding Issues Nationwide Recall of Glutathione, Myer’s Cocktail, and Tri-Immune Boost Due to Elevated Endotoxin Levels GSK prepares frontline FDA bid for Jideytro, its first lung cancer drug Merck, Gilead’s failed Trodelvy lung cancer trial shows better China results Home