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 early-to-mid stage trial of its malaria vaccine.
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 Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for the company's ANKTIVA and CAR-NK (PD-L1 t-haNK) for the reversal of Lymphopenia in
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 reactions in patients who weigh between 15 and 30 kilograms, the company said on Wednesday.
Raw Pet Food Recalled as FDA Issues Bird Flu Warning
Wild Coast Recalling Raw Cat Food on Bird Flu Contamination Risk, FDA Says
Bird flu cat food recall update: What pet owners need to know about the FDA’s latest warning
Trump FDA Pick Makary Endorses RFK Jr.’s Transparency Pledge
Marty Makary, President Donald Trump’s pick to lead the US Food and Drug Administration, said he’s ready to carry out the mission of instituting “radical transparency” called for by Health and Human Services Secretary Robert F.
Meeting of FDA vaccine advisers canceled, committee member says
This is the second cancellation to vaccine-related advisory panels since RFK Jr. took the helm at the Department of Health and Human Services.
What the FDA’s updated rules mean for securing America’s food chain—and how they affect you
As the industry scrambles to implement new laws on tracing and recalling contaminated food, lives, jobs, and billions of dollars are on the line
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FDA Approves 'Loss of Pulse Detection' Feature for Google Pixel Watch 3
Loss of pulse detection uses the watch's existing heart rate sensor and an AI algorithm that processes the data. It should launch by the end of March.
Trump Administration Cancels Meeting of FDA Vaccine Advisers, Risking Flu-Shot Delay
The Trump administration has canceled an upcoming meeting of the Food and Drug Administration’s vaccine advisory committee, a move that could complicate efforts to produce flu shots in time for the upcoming season.
US FDA issues labeling changes for testosterone products
The U.S. Food and Drug Administration said on Friday it issued new labeling changes for testosterone products based on results from clinical and post-market studies testing the products for blood pressure and cardiovascular effects.
Map Shows States With Listeria Cases as FDA Recalls Nutritional Shake
A nationwide recall of frozen nutritional shakes has been issued after a listeria outbreak tied to the drinks resulted in multiple hospitalizations and deaths across the United States, according to the U.
FDA moves to rehire medical device staffers fired only days earlier
Barely a week after mass firings at the Food and Drug Administration, some probationary staffers received unexpected news over the weekend: The government wants them back. Beginning Friday night, FDA employees overseeing medical devices and other key areas received calls and emails notifying them that their recent terminations had been “rescinded effective immediately,