How the FDA's approval for food additives works, and why experts say a loophole allows ...
Experts say that for decades, a legal loophole has allowed companies to include chemical additives that could be potentially ...
US FDA approves Mirum Pharma's genetic disorder drug
The U.S. Food and Drug Administration approved Mirum Pharmaceuticals' genetic disorder drug on Friday, making it the first ...
Ozempic and Wegovy officially moved off FDA’s drug shortage list
Ozempic and Wegovy, the widely popular forms of semaglutide sold to treat diabetes and obesity, have officially been removed ...
New FDA-Approved Diabetes Drug Slashes Heart Attack and Stroke Risk
Sotagliflozin significantly reduces heart attacks and strokes in high-risk patients with diabetes and kidney disease, ...
FDA announces end to Wegovy and Ozempic drug shortages, but it could mean higher prices
The FDA has announced that the shortage of Wegovy and Ozempic, medications used for weight loss and diabetes management, is ...
MedPage Today1 天
FDA Approves First Drug for Rare Lipid Storage Disorder
Chenodiol -- a naturally occurring human bile acid also known as chenodeoxycholic acid -- is the first FDA-approved drug indicated for the rare lipid storage disease and autosomal recessive genetic ...
KOMU5 天
FDA approves first drug to aid sleep apnea; drug also results in weight loss
The FDA approved a new drug called Zepbound, which activates GLP-1 to help with obstructive sleep apnea, while also resulting ...
infectiousdiseaseadvisor.com4 天
FDA Drug Approval Decisions Expected in March 2025
The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...
Healio1 天
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 ...
1MIRM : FDA Approves Mirum Pharmaceuticals' Drug As First For Genetic Disorder...
Mirum Pharmaceuticals' Ctexli wins FDA approval for CTX, a rare lipid storage disease. The company projects 2025 global sales of $420–$435 million.
WebMD5 天
FDA Approves New Drug for Rare Joint Tumor
Feb. 18, 2025 — The FDA has approved vimseltinib, a new oral drug for a rare, noncancerous tumor of the joints known as tenosynovial giant cell tumor (TGCT). It is intended for adults with ...
devdiscourse15 小时
Health Sector Shifts: From Drug Approvals to Supply Disruptions
The current state of health services highlights crucial sectors facing disruptions and developments, from US foreign aid freezes affecting disease control supply chains, to the FDA's actions on new ...