The National Law Review2d
GLP-1 Drugs: FDA Removes Semaglutide from the Drug Shortage List
On February 21, 2025, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order determining that the semaglutide ...
NJBIZ1d
Drug compounders sue FDA over Novo Nordisk’s Ozempic, Wegovy (updated)
Drug compounders aren’t ready to give up their ability to produce off-brand versions of Novo Nordisk’s weight-loss drug ...
Disrupted US vaccine meetings could threaten timelines, access and transparency around shots
Two long-planned vaccine meetings — one at the US Centers for Disease Control and another at the US Food and Drug ...
ImmunityBio receives FDA RMAT designation for Anktiva
ImmunityBio (IBRX) announced the U.S. Food and Drug Administration has granted Regenerative Medicine Advanced Therapy designation for ANKTIVA ...
manilatimes22h
VANTAGE FILES FDA DRUG MASTER FILE FOR VYCERIN™ API GLYCERIN, USP DESIGNED SPECIFICALLY TO MEET PHARMACEUTICAL FORMULATION NEEDS
Vantage Specialty Chemicals, Inc., (Vantage) today announced that its VYCERIN™ API Glycerin, USP is listed on the Drug Master File (DMF-040171) with the U.S. Food and Drug Administration (FDA).
Trying to eat healthy? FDA has a couple of changes to make it easier. What to know
"Under the updated 'healthy' claim, nutrient-dense foods that are encouraged by the Dietary Guidelines — vegetables, fruits, ...
Frozen shakes served at nursing homes recalled after being linked to numerous deaths, hospitalizations: FDA
The FDA announced that a food distributor is recalling all ReadyCare and Sysco Imperial Frozen Supplemental shakes, typically ...
FierceBiotech4d
FDA works to reverse layoffs, rehire lost staff: reports
After hundreds of FDA employees were suddenly laid off last weekend, including dozens at the agency’s device center, the ...
Healio3d
FDA approves expanded label for Izervay
This is a developing news story. Please check back soon for updates. The FDA approved expanded prescribing information for ...
manilatimes5h
Outlook Therapeutics® Re-Submits Biologics License Application for ONS-5010 as a Treatment for Wet AMD to the U.S. Food and Drug Administration
In the United States, ONS-5010 / LYTENAVA™ (bevacizumab-vikg) is investigational.
US FDA identifies cybersecurity risks in certain patient monitors
The U.S. Food and Drug Administration (FDA) said on Thursday it had identified three cybersecurity risks associated with ...
EurekAlert!2d
The Obesity Society commends FDA's resolution of obesity drug shortages, calls for enforcement against unauthorized compounding
ROCKVILLE, MD – The Obesity Society (TOS) acknowledges the U.S. Food and Drug Administration's (FDA) recent announcement declaring the end of shortages for Novo Nordisk's Wegovy and Ozempic; two ...