Regulatory Replimune cries foul on regulatory flexibility. But many Americans want a stricter FDA pharminent April 17, 2026
Regulatory FDA Approves Extended Dosing Interval for Regeneron’s EYLEA HD (aflibercept) pharminent April 15, 2026
Regulatory Lilly’s new obesity pill linked to ‘serious’ safety signals, FDA requests more data pharminent April 15, 2026
Regulatory FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development pharminent April 14, 2026
Regulatory MSD, Daiichi Sankyo’s ifinatamab deruxtecan receives FDA priority pharminent April 14, 2026
Regulatory MSD, Daiichi Sankyo’s ifinatamab deruxtecan receives FDA priority pharminent April 14, 2026
Regulatory IDEAYA and Servier’s eye cancer drug heads to FDA after delivering ‘best in class’ efficacy pharminent April 13, 2026
Regulatory FDA issues complete response letter to Replimune’s RP1 for melanoma pharminent April 13, 2026
Regulatory FDA issues complete response letter to Replimune’s RP1 for melanoma pharminent April 13, 2026
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
