Regulatory Partner’s Bizengri cleared by FDA for ultra-rare cancer days after winning priority voucher pharminent May 11, 2026
Regulatory Biogen, Eisai hit with 3-month delay for starting SubQ Alzheimer’s therapy pharminent May 8, 2026
Regulatory FDA Expands AI Capabilities and Completes Data Platform Consolidation pharminent May 6, 2026
Regulatory FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight pharminent May 6, 2026
Regulatory Lannett, Lanexa Biologics and Sunshine Lake secure FDA approval for Langlara pharminent May 5, 2026
Regulatory First FDA ODAC meeting without Pazdur highlights conceptual challenges with trial pharminent May 4, 2026
Regulatory Axsome receives FDA approval for Auvelity to treat Alzheimer’s agitation pharminent May 1, 2026
Regulatory FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia pharminent April 30, 2026
Regulatory UniQure, in ‘symbolic’ win, to seek UK approval of Huntington’s gene therapy pharminent April 30, 2026
Regulatory AstraZeneca faces uphill battle at upcoming adcomm in face of FDA questions pharminent April 29, 2026
Regulatory Intellia Initiates Rolling BLA Submission for In Vivo CRISPR Therapy in Hereditary Angioedema pharminent April 28, 2026
Regulatory Jazz Pharmaceuticals receives FDA Priority Review for Ziihera combo in first-line HER2+ GEA pharminent April 27, 2026
Regulatory Novartis secures pair of regulatory wins for skin disease and malaria treatments pharminent April 27, 2026
Regulatory UK medicines regulator grants marketing authorisation to Enflonsia for RSV prevention pharminent April 27, 2026
Regulatory Regulatory round-up: Novartis, Sanofi and Arrowhead secure CHMP blessings pharminent April 24, 2026
Regulatory FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program pharminent April 23, 2026
Regulatory Unnamed pharma files citizen petition targeting FDA’s trove of rejection letters pharminent April 23, 2026
Regulatory Pfizer and Astellas secure FDA priority review for Padcev MIBC combo therapy pharminent April 21, 2026
Regulatory Pfizer and Astellas secure FDA priority review for Padcev MIBC combo therapy pharminent April 21, 2026
Regulatory MSD secures EC approval for Enflonsia to prevent infant RSV infection pharminent April 20, 2026
