US FDA expands use of ARS Pharma's allergic reaction nasal spray in 15-30 kg patients
The U.S. Food and Drug Administration approved the expanded use of ARS Pharmaceuticals' nasal spray for severe allergic ...
US FDA expands use of allergic reaction nasal spray in people between 15-30 kilograms
The U.S. Food and Drug Administration approved the expanded use of ARS Pharmaceuticals' nasal spray for severe allergic ...
Musk’s DOGE Cuts Target FDA Lab Guarding US Drug Supply
A key lab that oversees US pharmaceutical safety is in limbo following moves by the Department of Government Efficiency, ...
U.S. FDA places clinical hold on BioNTech's malaria vaccine study
BioNTech said in a regulatory filing on Tuesday the U.S. Food and Drug Administration has placed a clinical hold on an ...
FiercePharma18h
Granules slammed in FDA warning letter detailing discarded documents, intruding birds at Indian plant
Shortly after making an M&A play to break into the CDMO business, Granules’ manufacturing bona fides have come under fire in ...
The Floridian6h
Trump’s FDA Pick Faces Big Test on Tobacco Policy
President Donald Trump’s nominee to head the Food and Drug Administration (FDA), Martin Makary, is an incredibly credentialed ...
ImmunityBio Receives FDA RMAT Designation for ANKTIVA and CAR-NK (PD-L1 t-haNK) to Achieve Reversal of Lymphopenia in Pancreatic Cancer Patients
Culver City-based ImmunityBio, Inc., a leading immunotherapy company, has announced that the U.S. Food and Drug ...
STAT1d
FDA scolds drugmaker over promotion that touts ‘misleading’ comparison with generics
For what appears to be the first time, the FDA scolded a company for a promotional display that falsely claimed its ...
Trump's FDA Staff Cuts Weigh on Agency's Drug Oversight Work
The Trump administration’s moves to shrink the federal workforce put the FDA’s ability to regulate drugs and oversee the ...
FiercePharma17h
FDA blasts Edenbridge over 'misleading' exhibit booth panel
The FDA has sent its first untitled letter of 2025, hitting Edenbridge Pharmaceuticals with a notice after assessin | The FDA ...
STAT2d
Marty Makary, Trump nominee to lead FDA, pledges to avoid conflicts if confirmed
Marty Makary, President Trump’s pick to be FDA commissioner, promised to step down as an adviser to various health tech, ...
USA Today12d
Shortage of popular drugs Wegovy and Ozempic is over, FDA says.
In a statement, the FDA said it confirmed Novo Nordisk's "stated product availability and manufacturing capacity" of these prescription drugs meets or exceeds current and projected demand.