FDA weighs changes to a long-standing labeling rule for dietary supplements and will temporarily exercise enforcement discretion on certain disclaimer...
FDA warns Brookhaven, GA-based Ponya Therapeutics about violations of regulations governing human cells, tissues, and cellular and tissue-based produc...
FDA clears a Lumos Labs 510(k) for LumosityRx, a prescription digital therapeutic intended to improve attention in adults with attention-deficit/hyper...
Roche reports positive Phase 3 lidERA trial results for its giredestrant selective estrogen receptor degrader endocrine therapy in some breast cancer ...
Reuters reports that Daniel McMullen, the former director of the CDRH Office of Neurological and Physical Medicine Devices, has joined Elon Musks Neur...
The U.S. government urges the Supreme Court to take up a patent-infringement dispute to decide whether generic drugmakers may face liability for induc...
Researchers say that the enhanced FDA regulatory authority from the 2017 FDA Amendments Act did not significantly change the time to first agency post...
The Washington Legal Foundation cautions that the Trump administrations ongoing crackdown on direct-to-consumer pharmaceutical advertising is on a col...
