Drug approvals, label changes, and FDA drug news.
FDA announced that it is piloting one-day inspectional assessments, as part of a broader initiative to make its inspectional resources more targeted and efficient.
FDA today authorized the marketing of four Glas electronic nicotine delivery systems (ENDS) through the premarket tobacco product application (PMTA) pathway.
FDA is announcing that it issued a “safe to proceed” letter to Revolution Medicines, allowing the sponsor to initiate an expanded access treatment protocol (EAP) for its experimental pancreatic cancer drug, daraxonrasib.
The U.S. Food and Drug Administration today approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with dementia due to Alzheimer’s disease in adults.
FDA is proposing to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances.
FDA announces results from the largest and most rigorous examination ever conducted focused on chemical contaminants in infant formula available on the U.S. market.
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Daiichi Sankyo
On April 18, President Trump issued an Executive Order directing the U.S. Department of Health and Human Services (HHS) to accelerate access to treatments for patients with serious mental illness, including devastating, complex, and treatment-resistant conditions.
The U.S. Food and Drug Administration today approved Otarmeni (lunsotogene parvec-cwha), the first-ever dual adeno-associated virus (AAV) vector-based gene therapy.
Since publishing roadmap last April, agency has successfully launched several key initiatives to replace animal testing with better alternatives
Efficacy supplement (new or revised indication). injectable, intravenous. Sponsor: Incyte Corp
Efficacy supplement (new or revised indication). tablet, oral. Sponsor: Abbvie
Efficacy supplement (new or revised indication). powder, inhalation. Sponsor: Mannkind
Efficacy supplement (new or revised indication). implant, implantation. Sponsor: Organon
Efficacy supplement (new or revised indication). injectable, intravenous. Sponsor: Incyte Corp
Original biologic license approval. injection. Sponsor: Glaxosmithkline Llc
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Daiichi Sankyo
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Astrazeneca Uk Ltd
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Genentech Inc
Efficacy supplement (new or revised indication). capsule, oral. Sponsor: Astrazeneca
Efficacy supplement (new or revised indication). capsule, oral. Sponsor: Abbvie
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Lundbeck Seattle Biopharmaceuticals, Inc.
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Genentech Inc
Efficacy supplement (new or revised indication). injectable, injection. Sponsor: Genentech Inc