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
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Regulatory FDA Issues Draft Guidance on Genome Editing Safety Standards to Advance Gene Therapy Development pharminent April 14, 2026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
