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 ...
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 ...
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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 ...
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Astellas nabs class-first FDA approval for CLDN18.2 gastric cancer med Vyloy
After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer ...
Ex-FDA food expert reveals worst cereal in America with link to cancer
An ex-FDA employee has revealed what he claims is the most harmful breakfast cereal on the U.S. market.
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EU drug reviewers back Novo Nordisk’s FDA-rejected hemophilia drug, snub PTC’s Translarna again
After hitting a wall with the FDA last year, Novo Nordisk has picked up backing from European drug reviewers for its novel ...