FDA clears a NantHealth 510(k) for its Omics Core, a whole exome tumor-normal in vitro diagnostic that measures overall tumor mutational burden in can...
FDA grants X4 Pharmaceuticals a breakthrough therapy designation for mavorixafor for the treatment of adult patients with WHIM (Warts, Hypogammaglobul...
FDA places a clinical hold on a Marker Therapeutics planned Phase 2 study of its MultiTAA T-cell therapy in post-allogeneic hematopoietic stem cell tr...
Researchers call on FDA to update guidances on endpoints for developing anti-infective drugs.
The Hill reports the Trump administration is proposing to lower some drug prices by ensuring that prices in this country are lower than comparable pri...
Eye on FDA notes a reduction in the number of drug-related advisory committee meetings this year and whether this can be seen as less transparency in ...
The Stericycle Expert Solutions third quarter recall index shows a lower number of prescription drug recalls and a very high number of medical device ...
Braeburn says its Brixadi treatment for opioid use disorder is available to be marketed 12/1/20 after FDA revoked the orphan drug designation for Indi...