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 ...
FDA pick may differ from HHS head RFK Jr. on some key areas
President Donald Trump’s pick to lead the Food and Drug Administration is set to face the Senate Health, Education, Labor and ...
Trump’s FDA pick made his name by bashing the medical establishment. Soon he may be leading it
Food and Drug Administration nominee Dr. Marty Makary is known for his contrarian views and fiery criticism of traditional ...
Musk’s DOGE Cuts Target FDA Lab Guarding US Drug Supply
A key lab that oversees US pharmaceutical safety is in limbo due to cuts from the Department of Government Efficiency this ...
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 ...
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 ...
FiercePharma12h
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 ...
FiercePharma10h
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 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 ...
FDA Expands Indication of Dust Mite Allergy Drug to Include Young Children
The U.S. Food and Drug Administration has expanded its indication of Odactra, a house dust mite allergen tablet, for the treatment of house dust mite-induced allergic rhinitis, with or without ...
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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 ...