FDA Approves Zepbound as a New Weight-Loss Drug
The U.S. Food and Drug Administration has approved Eli Lilly’s tirzepatide medication, which is branded as Mounjaro for diabetes, under a new brand for weight loss as well.
Complement C5 Inhibitor Zilucoplan Is Approved by FDA to Treat MG
UCB Pharma’s investigational agent zilucoplan, a complement C5 inhibitor, to treat patients with myasthenia gravis has been approved by the U.S. Food and Drug Administration under the market name Zilbrysq.
FDA Approves Biosimilar to ACTMRA
The U.S. Food and Drug Administration has approved Biogen’s tocilizumab-bavi (TOFIDENCE), a biosimilar option referencing ACTMRA, to treat moderately to severely active rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (PJIA) and systemic juvenile idiopathic arthritis (JIA).
FDA Approves CRYOcheck Factor VIII Deficient Plasma with VWF
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Precision BioLogic’s CRYOcheck Factor VIII (FVIII) Deficient Plasma with von Willebrand factor (VWF), opening the pathway for the company to launch the product in the U.S.
FDA Converts Leqembi to Traditional Approval to Treat Alzheimer’s
The U.S. Food and Drug Administration (FDA) has converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s disease, to traditional approval following a determination that a confirmatory trial verified clinical benefit.
FDA Retires Monovalent COVID-19 Vaccines
The U.S. Food and Drug Administration has amended the emergency use authorizations of the. Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals.
Pfizer’s LITFULO for Severe Alopecia Areata Approved by FDA
The U.S. Food and Drug Administration has approved LITFULO (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata.
FDA Approves Roche’s Columvi to Treat Diffuse Large B-Cell Lymphoma in Adults
The U.S. Food and Drug Administration has approved Roche’s Columvi, an antibody-based therapy chemically known as glofitamab.
Drug Granted Fast Track Approval to Treat Refractory Lupus Nephritis
The US Food and Drug Administration has granted fast track designation for Kyverna Therapeutics’ KYV-101 to treat refractory lupus nephritis.
First Once-Daily Oral Plaque Psoriasis Drug Approved by FDA
The U.S. Food and Drug Administration has approved Sotyktu (deucravacitinib), a once-daily oral pill by Bristol Myers Squibb, for adults who have plaque psoriasis (a chronic, systemic, immune-mediated disease) severe enough to make them candidates for systemic therapy and phototherapy.