Regulatory GSK again pulls application for leucovorin, touted by FDA as potential autism treatment pharminent April 10, 2026
Regulatory Teva Receives FDA Approval of Denosumab Biosimilar and Filing Acceptances by FDA and EMA For Omalizumab Biosimilar pharminent April 9, 2026
Regulatory FDA seeks permanent future for rare pediatric priority review vouchers pharminent April 9, 2026
Regulatory FDA Seeks Expanded Authority To Regulate Postapproval Manufacturing Changes pharminent April 7, 2026
Regulatory MSD secures EC clearance for Keytruda combination therapy for ovarian cancer pharminent April 6, 2026
Regulatory Eli Lilly wins FDA approval for weight loss pill, tees up Novo rivalry pharminent April 2, 2026
Regulatory FDA approves Lilly obesity pill, triggering battle with Novo Nordisk pharminent April 1, 2026
Regulatory Eli Lilly’s Oral Obesity Pill Approved, Kicking Off Renewed Novo Rivalry pharminent April 1, 2026
Regulatory FDA Approves First New Molecular Entity Under National Priority Voucher Program pharminent April 1, 2026
Regulatory FDA Ties Amgen’s Rare Inflammatory Disease Drug to Eight Deaths, Dozens of Liver Injuries pharminent April 1, 2026
Regulatory FDA, after turbulent year, leaves drugmakers guessing on its direction pharminent April 1, 2026
Regulatory S16 Ep43: FDA Approval Insights: Rucaparib for BRCA Mutation-Associated mCRPC: With David Morris, MD, FACS; and Alan H. Bryce, MD pharminent March 31, 2026
Regulatory S16 Ep40: FDA Approval Insights: Zongertinib for HER2 TKD-Mutated NSCLC: With Julia Rotow, MD; and Martin Dietrich, MD, PhD pharminent March 30, 2026
Regulatory Biogen Bounces Back With FDA Nod for High-Dose Spinal Muscular Atrophy Drug pharminent March 30, 2026
Regulatory Accord, Intas, and Bio-Thera File Four IPRs Against Janssen Golimumab Patents pharminent March 27, 2026
Regulatory FDA clears Denali drug in ‘clear step’ for rare disease biotechs pharminent March 26, 2026
Regulatory FDA seeks feedback on voucher program; Study data lift ‘overhang’ on Insmed shares pharminent March 24, 2026
Regulatory Pfizer, Valneva to seek approval of Lyme disease vaccine despite mixed study results pharminent March 23, 2026
