FDA enforcement will focus on restricting GLP-1 APIs in mass-marketed, nonapproved compounded products to address unverifiable quality, safety, and efficacy under the FD&C Act. Appropriate compounding ...
All of the September 9 enforcement letters citing DTC promotional content were issued at the center-level by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation ...
On Feb. 6, 2026, FDA announced that it would take action to restrict access to GLP-1 ingredients for non-FDA approved compounded drugs. On the same day, the HHS General Counsel announced on social ...
The FDA approved marketing of the direct-to-consumer smartphone app Natural Cycles as a method of contraception to prevent pregnancy Aug. 10. The app, developed by the Swedish company Natural Cycles ...
The U.S. Food and Drug Administration (FDA) on Thursday informed Aquestive Therapeutics, Inc. (NASDAQ:AQST) that an advisory committee meeting is not required for Anaphylm (dibutepinephrine) ...
Following the FDA’s September announcement of a crackdown on direct-to-consumer drug marketing practices and the subsequent flurry of untitled and warning letters criticizing dozens of Big Pharma ads, ...
President Donald Trump has delivered another blow in his ongoing battle with the pharma industry, signing a memorandum on Tuesday that directs the FDA to rein in direct-to-consumer (DTC) drug ...
Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. WASHINGTON — President Trump ...
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