FDA asks Texas court to shut down COVID-19 vaccine records lawsuit
The U.S. Food and Drug Administration has asked a federal judge in Texas to throw out a public records lawsuit related to ...
Nationwide Antidepressant Recall Update As FDA Sets Risk Class
The recall of the Duloxetine Delayed-Release Capsules, produced by Towa Pharmaceutical Europe, was initiated on October 10 ...
Her breast density camouflaged her cancer. She says new FDA regulations are "a gift."
"If I have dense breast tissue, am I more prone to get cancer?" CBS News New York's Kristine Johnson asked. "The answer is, ...
US FDA pauses Novavax's trial of combo COVID-flu shot on safety concerns
The U.S. Food and Drug Administration has put Novavax's trial of an experimental COVID-flu vaccine combination on hold after ...
Novavax Stock Plunges After FDA Pauses Covid, Flu Vaccine Trials
Novavax shares tumbled after the Food and Drug Administration put a clinical hold on its testing applications for a combined ...
Novavax Says FDA Puts Clinical Hold on Covid-19, Flu Vaccines
Novavax said federal regulators put a clinical hold on its application for a combination Covid-19 and influenza vaccine and ...
Injectable drug to ease advanced Parkinson's disease symptoms approved by FDA
The FDA on Thursday approved an injectable drug that eased Parkinson's disease symptoms and improved motor fluctuations in ...
US FDA expands approval for Avadel's sleep disorder drug
The U.S. Food and Drug Administration has approved Avadel Pharmaceuticals' sleep disorder drug for children aged 7 years and ...
FDA will reconsider decision barring copycat versions of Lilly weight loss drug
The Food and Drug Administration (FDA) said it will reconsider its decision to remove Eli Lilly’s blockbuster weight loss and ...
Medscape3d
FDA Approves Fifth Ustekinumab Biosimilar
The drug is approved for multiple inflammatory conditions and is expected to launch in the first half of 2025.
Major Airline Cancels Meal Service After FDA Flags ‘Food Safety Issue'
A major airline was forced to cancel meal service on hundreds of flights after the Food and Drug Administration (FDA) ...
BioSpace9h
FDA Pushes Back PDUFA Dates for Amgen and Intercept
The regulator has delayed its respective decision dates on whether to grant full approval to Amgen’s Lumakras in metastatic ...