Regulatory FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients pharminent June 2, 2026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
Regulatory Regulatory round-up: A month of key FDA approvals for cancer drugs pharminent May 14, 2026
Regulatory FDA turns to old drugs to address new diseases, persistent medical needs pharminent May 12, 2026
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
