A Clinical Trial Vanguard column demonstrates how synthetic biology is outstripping FDAs regulatory framework under the Supreme Courts Loper Bright de...
FDA releases the form FDA-483 with five repeat observations from an inspection at Houston, TX-based Revive Rx Pharmacy.
FDA releases a form FDA-483 with six observations from an inspection at Indias Global Calcium active pharmaceutical ingredient manufacturing facility....
Consumers for Dental Choice and two other advocacy groups again petition FDA to ban the use of mercury amalgams in dentistry, especially for vulnerabl...
FDA approves a Regeneron Pharmaceuticals BLA for Otarmeni (lunsotogene parvec-cwha), the first gene therapy for a form of inherited hearing loss.
FDA commissioner Marty Makary says the agency is not planning to eliminate direct-to-consumer pharmaceutical advertising, even as it ramps up enforcem...
Researchers describe FDA and congressional actions that will improve the ability of the new plausible mechanism pathway to lead to the development of ...
Gilead calls on FDA to rescind its decision to file a Cipla 505(b)(2) NDA for an apparent duplicate of Gileads Descovy.
