Healio17h
Families ‘thrilled’ with omalizumab in the year since its approval for food allergy
As we approach the first anniversary of omalizumab’s approval for food allergy, its use is “definitely going to grow,” Robert ...
FDA says Ozempic shortage is over, chilling boom in off-brand versions
The FDA has now resolved the shortages of Novo Nordisk’s and Eli Lilly’s blockbuster weight-loss drugs, which could spell the ...
Yearslong shortage of popular weight-loss and diabetes drugs is resolved, FDA says
Federal regulators say shortages of Ozempic and Wegovy have been resolved, as supplies of popular diabetes and obesity ...
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 ...
FiercePharma19h
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 ...
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 ...
Generic Wegovy, Ozempic compounds may become harder to get as FDA removes drug from shortage list
Compounding pharmacies producing cheaper semaglutide products have been given notice they will soon have to stop, as the drug ...
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 ...
Senate Democrats press HHS over FDA firings
In letter, senators say recent staff firings could affect drug and device approval, food safety and public health threats.
Neurology Advisor23h
FDA Approves Tablet Form of Evrysdi for Spinal Muscular Atrophy
The US Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for people living with spinal muscular atrophy (SMA).
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 ...