The U.S. Food and Drug Administration has delayed a review of safety data for the abortion drug mifepristone at Commissioner Marty Makary's request, Bloomberg News reported on Monday, citing people familiar with the matter.
The U.S. Food and Drug Administration violated the law by imposing restrictions on accessing mifepristone, a medication for abortions and miscarriage management, a federal judge in Hawaii ruled Thursday.
Celltrion Inc., a leading South Korean biopharmaceutical company, said Friday its biosimilar for eye diseases has received approval for sale in the United States.
More packages of frozen shrimp potentially affected by radioactive contamination have been recalled, federal officials said Thursday.
The Food and Drug Administration is allowing vaping brand Juul to keep its e-cigarettes on the market, providing relief to a company that has struggled for years after being widely blamed for sparking the teen vaping trend.
The U.S. Food and Drug Administration (FDA) is currently conducting an on-site inspection of Samsung Biologics's production facilities in Korea, industry sources said Wednesday.
Celltrion, a major Korean biopharmaceutical firm, said Monday it has obtained an interchangeability approval for its biosimilar drug for autoimmune disease treatment in the United States.
Korean cosmetics face U.S. pullbacks and price hikes over FDA regulations and rising tariffs, sparking panic buying. Though MoCRA doesn't cover SPF, fear of stricter rules led brands to halt or reformulate products, raising concerns about access.
Celltrion, a major Korean biopharmaceutical firm, said Tuesday that its two new biosimilars for bone disease treatment, Stoboclo and Osenvelt, have obtained approval from the United States.
U.S. Food and Drug Administration employees reviewing Elon Musk’s brain implant company Neuralink were fired over the weekend as part of a broader purge of the federal work force, according to two sources with knowledge of the matter.
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