FDA clears a DeepEcho 510(k) for its artificial intelligence-based fetal ultrasound analysis platform.
FDA approves a Cycle Pharmaceuticals NDA for Harliku (nitisinone) tablets for reducing urine homogentisic acid in adult patients with alkaptonuria.
Two SheppardMullin attorneys say it remains to be seen whether a recent FDA Warning Letter to DRG Instruments about selling research-use-only (RUO) di...
FDA says it is reviewing all clinical trials that rely on a Biden administration exemption that allowed sensitive biological material, including DNA, ...
FDA places CBER Office of Therapeutic Products director Nicole Verdun and her deputy Rachael Anatol on administrative leave in the latest shake-up at ...
The FDA Office of Regulatory and Emerging Science publishes a report describing agency efforts to research cybersecurity and advanced manufacturing is...
Bavarian Nordic enters into an agreement to sell for $160 million a priority review voucher that was awarded for gaining approval of its chikungunya v...
A Texas federal judge rules FDA acted properly in removing Novo Nordisks Ozempic and Wegovy from its drug shortage list.
