United States Food and Drug Administration
FDA Advisory Panel Rejects Lykos’ MDMA Treatment for PTSD Despite Promising Results
MDMA, PTSD, FDA, Lykos Therapeutics, Psychopharmacologic Drugs Advisory Committee, psychedelic therapy
BMS Details Confirmatory Trial Win for KRAS Inhibitor Krazati
Bristol Myers Squibb, Krazati, KRAS inhibitor, confirmatory trial, non-small cell lung cancer (NSCLC), progression-free survival (PFS), chemotherapy, accelerated approval, FDA
Gilead’s Trodelvy Fails to Meet Primary Endpoint in Confirmatory Trial for Urothelial Cancer
Gilead Sciences, Trodelvy, urothelial cancer, TROPiCS-04 study, overall survival, antibody-drug conjugate, oncology, clinical trials, FDA approval
Gilead’s Trodelvy Fails to Meet Primary Endpoint in Lung Cancer Trial, but Shows Promise in Subgroup Analysis ###
Gilead Sciences, Trodelvy, Lung Cancer, ASCO, FDA, Clinical Trials, Oncology, Immunotherapy, Trop-2 Directed Antibody-Drug Conjugate
FDA Delays Dupixent Decision for Uncontrolled COPD Treatment, EU Panel Recommends Approval
Dupixent, dupilumab, COPD, FDA, EU approval, Sanofi, Regeneron, uncontrolled COPD, treatment delay
FDA Delays Dupixent Decision for COPD by Three Months, EMA Recommends Approval
FDA, Dupixent, COPD, EMA, Regeneron, Sanofi, Priority Review, PDUFA, Boreas, Notus, Phase III Trials
FDA Approves Tris Pharma’s Onyda XR, First Liquid Non-Stimulant ADHD Medication for Pediatric Patients ###
Tris Pharma, Onyda XR, ADHD, Non-stimulant, Liquid medication, Pediatric patients, FDA approval, Clonidine hydrochloride, Extended-release oral suspension, LiquiXR technology
Regulatory Tracker: Lilly’s Retevmo Secures Pediatric Cancer FDA Nod ###
Retevmo, Eli Lilly, FDA approval, pediatric cancer, RET-altered, thyroid cancer, solid tumors, accelerated approval, LIBRETTO-121 trial, selpercatinib
Biotech Roundup: Compugen, Nxera Milestone Payments; Insmed Seeks $650M Offering
Compugen, Nxera, milestone payments, Insmed, $650M offering, biotech, pharmaceuticals, Celcuity, Weave Bio, AstraZeneca, Novo Nordisk Foundation, FDA, LDT rule, BMS, Breyanzi, KRAS drug, Novartis
FDA Approves Amgen’s Bkemv, First Interchangeable Biosimilar to Soliris for Rare Blood Disorders ###
Bkemv, Soliris, FDA approval, Interchangeable biosimilar, Rare blood disorders, Paroxysmal nocturnal hemoglobinuria (PNH), Atypical hemolytic uremic syndrome (aHUS), Amgen, AstraZeneca, Alexion Pharmaceuticals