United States Food and Drug Administration
Cybin’s Psychedelic Breakthroughs: Advancing Mental Health Treatments
Cybin, psychedelic therapeutics, mental health treatments, deuterated psilocybin, deuterated DMT, clinical trials, FDA Breakthrough Therapy Designation.
FDA Approves Revuforj, a First-in-Class Menin Inhibitor, for Relapsed or Refractory Acute Leukemia with KMT2A Translocation
FDA approval, Revuforj, Menin inhibitor, Acute leukemia, KMT2A translocation, Relapsed or refractory, Syndax Pharmaceuticals
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.