Review [Publication Type]
FDA official said to step in and pause review of Novavax’s COVID-19 vaccine
United States Food and Drug Administration, COVID19 (disease), Vaccines, Novavax ‘s, Review [Publication Type], Novavax, Approved
Moderna CEO Reflects on 2024 Challenges and Advances in Shareholder Letter
Moderna, shareholder letter, 2024 review, RSV vaccine, COVID-19 vaccine, mRNA medicines, Stéphane Bancel
Dupixent (Dupilumab) Advances Towards FDA Approval for Chronic Spontaneous Urticaria (CSU) in 2025
Dupixent, Dupilumab, Chronic Spontaneous Urticaria (CSU), FDA Review, Sanofi, Regeneron, Biologic Medicine, Type 2 Inflammation, H1 Antihistamines
UK Regulator Approves Pharming’s Joenja for Rare Immune Disorder APDS, Leveraging FDA Review
Joenja, leniolisib, APDS, MHRA approval, FDA review, rare immune disorder, Pharming
Ascendis Hormone Replacement Therapy Faces Setback with FDA Review Extension
Ascendis Pharma, hormone replacement therapy, FDA review, delay, three-month extension.
Extended FDA Review Timeline for Ascendis’ Hormone Therapy
Ascendis Pharma, hormone therapy, FDA review, delay, 3 months extension.
FDA Unexpectedly Postpones Approval Decision for Eli Lilly’s Donanemab, Schedules AdComm Review
Donanemab, Eli Lilly, FDA delay, Approval postponement, Peripheral and Central Nervous System Drugs Advisory Committee (PCNS), Safety and efficacy review, Clinical trial results, Brain swelling and bleeding side effects, Accelerated approval declined, Leqembi and Aduhelm precedent, Full approval anticipated, Accelerated approval rejected.