The agency is missing deadlines and not responding to biotech companies, forcing some to push back clinical trials.

The FDA laid out a three-year roadmap to phase out animal toxicity testing in drug research. In addition to organoids and lab ...

Two Tony's Chocolonely products were recalled nationwide after multiple consumers outside North America reported finding ...

About one week after FDA announced a RIF, the agency began drafting a statement of work seeking contractors to do the same ...

In the wake of unprecedented workforce cuts at the FDA, former Commissioner Scott Gottlieb and an unnamed former CBER ...

The U.S. Food and Drug Administration on Monday warned consumers and pharmacies that fake versions of Ozempic, a drug to ...

The contractors would effectively replace most of the work done by more than 50 laid-off federal employees who handled travel ...

The FDA on Monday urged patients and doctors to check that their Ozempic prescriptions are legitimate after the agency seized ...

HHS Secretary Robert F. Kennedy Jr.’s sweeping layoffs across federal health agencies are disrupting the work of drug, ...

The US Food and Drug Administration announced Thursday that it will be phasing out a requirement that monoclonal antibodies ...

In an April 14 announcement, the FDA stated that Novo Nordisk — manufacturer of Ozempic and Wegovy — notified the agency that “several hundred units of counterfeit Ozempic (semaglutide) injection 1 mg ...

The FDA is phasing out an animal testing requirement for monoclonal antibody therapies in favor of testing drugs on ...