United States Food and Drug Administration
FDA Approves Danziten: A Breakthrough Nilotinib Treatment for Chronic Myeloid Leukemia Without Mealtime Restrictions
Danziten, Nilotinib, Chronic Myeloid Leukemia (CML), FDA Approval, Mealtime Restrictions, Azurity Pharmaceuticals
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
FDA Approves PTC Therapeutics’ Kebilidi, the First Gene Therapy Delivered Directly to the Brain for AADC Deficiency
PTC Therapeutics, Kebilidi, Gene Therapy, AADC Deficiency, FDA Approval, Brain-Delivered Therapy, Rare Genetic Disorder
Adaptimmune Prepares for Next FDA Submission Following Success in Pivotal Sarcoma Study
Adaptimmune, FDA submission, sarcoma study, afami-cel, lete-cel, cell therapy, synovial sarcoma, cancer treatment
FDA Denies Full Approval for Ocaliva in Primary Biliary Cholangitis, Accelerated Approval Stands
FDA, Ocaliva, Intercept Pharmaceuticals, primary biliary cholangitis, accelerated approval, rare liver disease
FDA Issues Second Clinical Hold on Kezar’s Zetomipzomib Program Within Two Months
Kezar Life Sciences, Zetomipzomib, FDA Clinical Hold, Lupus Nephritis, Autoimmune Hepatitis, Clinical Trials
Syndax’s Revumenib Shows Promising Results in Acute Leukemia Trials, Paving Way for FDA Approval
Revumenib, Acute Leukemia, AUGMENT-101, SAVE Trial, BEAT AML, Syndax Pharmaceuticals, FDA Approval
Trump’s Return to the White House: Potential Implications for FDA and Biopharma M&A
Trump, FDA, Biopharma, M&A, Healthcare Policy, Robert F. Kennedy Jr.
Sarepta Discontinues Development of SRP-5051 for Duchenne Muscular Dystrophy Due to Safety Concerns
Sarepta Therapeutics, SRP-5051, Duchenne muscular dystrophy, DMD, safety concerns, hypomagnesemia, FDA, clinical trials
Sarepta Therapeutics Halts Development of Vesleteplirsen, a Next-Generation Exon-Skipping Therapy for Duchenne Muscular Dystrophy
Sarepta Therapeutics, Vesleteplirsen (SRP-5051), Duchenne Muscular Dystrophy (DMD), Exon-Skipping Therapy, FDA Feedback, Therapeutic Landscape