An FDA advisory committee splits on whether the efficacy data support approval for a ChemoCentryx NDA for avacopan targeting anti-neutrophil cytoplasm...
FDA grants Viome a breakthrough device designation for its proprietary mRNA analysis technology combined with its artificial intelligence platform for...
Federal Register notice: FDA sends to OMB an information collection extension entitled 513(g) Request for Information for device classification inquir...
FDA gives priority review to two applications from Merck and Eisai for the combination of Keytruda and Lenvima to treat some cases of advanced renal c...
Federal Register notice: FDA announces a 6/9 Pharmacy Compounding Advisory Committee meeting to discuss four bulk drug substances.
A researcher from a British university says only three of 13 childrens vaccines tested contained the aluminum level stated in the labeling.
American Tort Reform Association president Tiger Joyce says the Supreme Court should hear Janssens appeal of a Philadelphia court decision that contra...
A bipartisan group of 20 House members urge the Appropriations Committee not to block an FDA proposal to allow digital sharing of labeling information...