Fda
FDA approves first treatment for rare lipid storage disease
The FDA has approved Ctexli for the treatment of cerebrotendinous xanthomatosis (CTX), a rare lipid storage disease, in adults.
FDA clears investigational new drug application for Zabalafin Hydrogel
The investigational new drug application for Zabalafin Hydrogel for the treatment of mild to moderate atopic dermatitis has been cleared by the FDA, Alphyn Biologics announced in a press release.
FDA removes semaglutide from drug shortage list
The FDA has removed semaglutide from its drug shortage list after the agency determined the current supply of the drug can meet present and future demand, Novo Nordisk and the FDA announced.
FDA accepts sBLA, grants priority review for Dupixent to treat bullous pemphigoid
The supplemental biologics license application for Dupixent for the treatment of bullous pemphigoid in adults has been accepted by the FDA for priority review, Sanofi announced in a press release.
Injectable naltrexone tops disulfiram, acamprosate as safer option in alcohol use disorder
Injectable naltrexone had a more favorable gastrointestinal and liver safety profile compared with other medications for alcohol use disorder, according to a research letter published in Clinical Gastroenterology and Hepatology.
FDA clears surgical system for viscoelastic fluid delivery
The FDA granted 510(k) clearance for the VIA360 surgical system, which is designed to deliver viscoelastic fluid during ophthalmic surgeries, according to a press release from New World Medical.
FDA sets date for decision on twice-yearly shots to prevent HIV
The FDA has accepted Gilead Sciences’ new drug application for lenacapavir as a long-lasting injectable to prevent HIV infection and set a date of June 19 to decide on its approval, Gilead announced Tuesday.
FDA accepts IND for allogenic CAR T-cell therapy that could bypass lymphodepletion
The FDA has accepted an investigational new drug application for ALLO-329, an allogeneic chimeric antigen receptor T-cell therapy that may bypass lymphodepletion, paving the way for a phase 1 trial in lupus and other autoimmune diseases.
FDA approves two new biosimilars of denosumab
The FDA has approved two new biosimilars of denosumab to treat osteoporosis, increase bone mass, prevent skeletal-related events for people with multiple myeloma and other indications, Samsung Bioepis announced.
FDA approves Gomekli for neurofibromatosis type 1 with plexiform neurofibromas
The FDA has approved an oral, small molecule MEK inhibitor for adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection.