Regulatory Disc’s FDA meeting sets ‘clear path’ for embattled rare blood disease drug pharminent June 10, 2026
Regulatory ADA: Lilly bests Novo again, takes GLP-1 pill Foundayo to FDA for diabetes approval pharminent June 9, 2026
Regulatory Pfizer’s Hympavzi secures FDA expanded indications for haemophilia pharminent June 9, 2026
Regulatory Biogen’s salanersen gains FDA breakthrough therapy designation for SMA pharminent June 5, 2026
Regulatory FDA taps prior knowledge to expedite cell and gene therapy development pharminent June 3, 2026
Regulatory FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients pharminent June 2, 2026
Regulatory FDA approves AstraZeneca’s Imfinzi-BCG combination for NMIBC therapy pharminent June 1, 2026
Regulatory Replimune gives cancer immunotherapy a third try after FDA leadership shakeup pharminent May 29, 2026
Regulatory Pazdur declines to announce candidacy for vacated FDA commissioner role pharminent May 20, 2026
Regulatory VERTANICAL’s VER-01 gains FDA breakthrough status for low back pain pharminent May 19, 2026
Regulatory AstraZeneca wins nod for blood pressure pill, opening new class of hypertension drugs pharminent May 18, 2026
Regulatory FDA approves Enhertu for two HER2-positive early breast cancer indications pharminent May 18, 2026
Regulatory With new data, Regenxbio to seek FDA approval of Duchenne gene therapy pharminent May 14, 2026
