The potential disruptions to FDA’s already strained inspection force are so great that agency leaders recently expedited plans to hire outside contractors to replace some fired workers ...

Health and Human Services Secretary Robert F. Kennedy Jr. and his allies rallied around removing industry influence from the Food and Drug Administration as part of their quest to Make America ...

The Supreme Court on Wednesday upheld FDA actions to keep certain flavored e-cigarettes off the market, unanimously backing some of the agency’s approval process but sending an issue back to a ...

Two former FDA leaders have taken to social media to say that the agency as we know it no longer exists. Robert Califf, who stepped down from his post as Food and Drug Administration commissioner ...

The U.S. Food and Drug Administration recently authorized the marketing of 20 nicotine pouch products under the Zyn brand, including flavors like Wintergreen and the "unflavored" Chill. That ...

An internal email obtained by The Associated Press states that FDA leadership are “allowing review staff and supervisors to resume telework” at least two days a week. The policy shift was ...

The agency updates and modifies the alerts as needed. Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. Click here to go to the FDA page with links to ...

According to GSK, the last time the FDA cleared a new class of antibiotics for uncomplicated UTIs was in 1996, with the approval of fosfomycin. (Last year, the agency approved the drug Pivya for ...

The Food and Drug Administration on Monday urged patients and doctors to check that their Ozempic prescriptions are legitimate after the agency seized several hundred units of fake versions of ...

The U.S. Food and Drug Administration (FDA) and Novo Nordisk are warning people not to use counterfeit semaglutide 1.0 mg (Ozempic injection) found in the US drug supply chain. Novo Nordisk ...

The FDA’s top vaccine official, Dr. Peter Marks, abruptly resigned weeks after anti-vaccine activist Robert F. Kennedy took over as the head of Health and Humans Services. A person familiar with ...

近期，FDA 官方网站宣布计划逐步取消单抗和其他药物的动物实验要求。而这一消息迅速引发市场连锁反应，尤其是对国内CRO（合同研究组织 ...