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Exclusive: US FDA asks some fired pharma user fee negotiation staff to return
The U.S. Food and Drug Administration is asking some of its recently fired staff responsible for critically important funding ...
Neuralink's speech restoration device gets FDA's 'breakthrough' tag
Neuralink has received the U.S. Food and Drug Administration's "breakthrough" tag for its device to restore communication for ...
FDA delays decision on Stealth BioTherapeutics' rare genetic disorder drug
The U.S. Food and Drug Administration has delayed its decision on marketing approval for Stealth BioTherapeutics' treatment ...
US FDA chief says firings won't hinder agency's target dates for drug reviews
The U.S. Food and Drug Administration will meet its targets for completing reviews of new drugs despite mass firings at the agency under the Trump administration, its chief said.
As FDA delays Novavax' COVID vaccine approval, patients fight back
Thousands of Americans campaigning for the Novavax COVID-19 booster got some good news this week: the FDA signaled it might ...
US FDA suspends milk quality tests amid workforce cuts
The Food and Drug Administration is suspending a quality control program for testing of fluid milk and other dairy products ...
US FDA approves syringe version of Argenx's immune disorder drug
The U.S. Food and Drug Administration has approved a prefilled syringe version of Netherlands-based Argenx SE's blockbuster ...
US Justice Department unit for drug and food safety cases being disbanded
A Justice Department unit that handles criminal and civil enforcement of U.S. food and drug safety laws is being disbanded as ...
US FDA accepts Novo Nordisk's application for oral Wegovy for weight loss
The U.S. Food and Drug Administration has accepted Novo Nordisk's marketing application for an oral version of its ...
US FDA approves J&J's immune disorder drug
The U.S. Food and Drug Administration on Wednesday approved Johnson & Johnson's drug to treat a type of muscle-weakening ...
Novavax shares soar after FDA request raises hope for COVID vaccine approval
Novavax said on Wednesday U.S. regulators asked the company to produce more data on its COVID-19 vaccine if it gets full ...