FDA says the Botanical Safety Consortium has been formally convened under a memorandum of understanding between FDA and two research groups
FDA approves BeiGenes Brukinsa capsules to treat some adults with mantle cell lymphoma.
FDA releases an FDA-483 with four inspection observations on an inspection at Isorx Corp.
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...