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 ...
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, ...
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 ...
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 ...
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 ...
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 ...
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 ...
FiercePharma19h
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 ...
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 ...
Trump’s FDA Cuts Are Putting Drug Development at Risk
New SEC filings from pharmaceutical companies reveal Donald Trump and Elon Musk’s cost-cutting measures could slow drug ...
Examining The FDA's Recommendations For AI-Enabled Medical Devices
The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...
Modern Healthcare12h
FDA labels Philips' recall of Tack Endovascular Systems a Class I
Complications with the implant used to treat blood vessel dissection after balloon angioplasty or stent placement can result ...