Eli Lilly reports positive Phase 3 results for its BTK inhibitor Jaypirca (pirtobrutinib) in combination with venetoclax and rituximab.
Significant operational hurdles remain before FDA's Plausible Mechanism Framework can be broadly implemented, according to a commentary published by S...
FDA increases scrutiny of telehealth companies marketing compounded drugs, warning that some firms are making false or misleading claims about compoun...
A citizen petition urges FDA to impose an immediate moratorium on the use of gadolinium-based contrast agents in MRI scans.
FDA posts a draft guidance to assist NDA sponsors in properly submitting patent information for listing in the agency's Orange Book.
FDA approves Merck's Welireg (belzutifan) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for certain patients with renal cell c...
A just-posted notice from Amgen outlines the basis for the company's defense of why its ANCA-associated vasculitis drug Tavneos should not be withdraw...
Jazz Pharmaceuticals says its Phase 3 LAGOON study evaluating Zepzelca (lurbinectedin) in relapsed small cell lung cancer failed to meet its primary e...
