FDA extends its review of a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondria-targeted therapeutic for treating Barth syndro...
FDA grants Zai Lab an orphan drug designation to ZL-1310, an antibody-drug conjugate for treating small cell lung cancer.
Three Ropes & Gray attorneys review major FDA-related enforcement cases in 2024 and say it is impossible to predict with certainty the direction the n...
Two medical device stakeholders suggest ways for FDA to regulate generative AI and foundation model-enabled medical devices.
FDA says it is adding a Boxed Warning for anaphylaxis to the labeling for Tevas multiple sclerosis drug Copaxone and its Sandoz generic.
CBER director Peter Marks report for 2024 discusses Center approval of 67 products it says integrated advances in science and technology.
The U.S. Court of Federal Claims grants FDA summary judgment on the pleadings and rejects Vandas 5th Amendment taking argument about FDA disclosure of...
The union representing FDA employees sues President Trump over efforts to replace many Civil Service workers with political appointees.
