FDA approves Astellas' gastric cancer therapy
The U.S. Food and Drug Administration approved Astellas' therapy to treat a type of gastric cancer, the health regulator's ...
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 ...
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, ...
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 ...
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 ...
Sagimet Soars: FDA Breakthrough Therapy Designation And Lancet Review Validate Denifanstat
Discover why Sagimet Biosciences' Denifanstat is a top contender in treating MASH, with FDA designation and strong financials ...
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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 ...
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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 ...