FDA says Ozempic shortage is over, chilling boom in off-brand versions
The FDA has now resolved the shortages of Novo Nordisk and Eli Lilly’s blockbuster weight-loss drugs, which could spell the ...
infectiousdiseaseadvisor.com2d
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 ...
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 ...
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 ...
Novo's Wegovy and Ozempic removed from US FDA shortage list, compounders on notice
The U.S. Food and Drug Administration said on Friday there was no longer a shortage of Novo Nordisk's popular weight-loss and ...
Ozempic and Wegovy are no longer in shortage, FDA says
Blockbuster weight-loss and diabetes drugs Wegovy and Ozempic are no longer in shortage, the US Food and Drug Administration said on Friday.
FiercePharma4h
After asset purchase from Travere, Mirum's Ctexli crosses FDA finish line in rare metabolic disorder
The approval makes chenodiol—already cleared for decades to treat radiolucent gallstones under the brand name Chenodal—the ...
Monthly Prescribing Reference1d
FDA Approves Vimkunya to Protect Against Chikungunya Virus
Vimkunya is supplied as an injectable suspension; the vaccine is administered intramuscularly as a single 0.8mL dose.