The FDA is still reviewing a label expansion for GSK’s respiratory drug Nucala in chronic obstructive pulmonary disease despite the May 7 target date for a decision, the company confirmed to Endpoints ...

Boston-based Verastem Oncology on Thursday won accelerated approval from the FDA for Avmapki Fakzynja as a second-line ...

Vor Bio, founded by famed cancer biologist Siddhartha Mukherjee, is looking for a way out. Its decision to pursue strategic ...

Fyodor Urnov and Kiran Musunuru advocate for streamlined CRISPR treatments for rare genetic diseases, partnering with Danaher ...

After working off $20 million in seed funding for about four years, HAYA Therapeutics tapped the funding well and came back ...

Lan­theus fi­nal­ly came clean about the fate of its ex­per­i­men­tal ra­dio­phar­ma­ceu­ti­cal for prostate can­cer, ...

FDA advisors to meet May 22 on Covid vaccine strain selection amid scrutiny from Kennedy's HHS, as Novavax awaits approval ...

Gilead is the latest drugmaker to announce that it’s pouring billions of dollars into its manufacturing and R&D operations in ...

The FDA announced a two-day meeting of its Oncologic Drugs Advisory Committee (ODAC) later this month to review cancer drugs ...

A leading pharmaceutical trade group urged the Department of Commerce not to place tariffs on the sector as the window for ...

Vinay Prasad named to replace Peter Marks as head of FDA's Center for Biologics Evaluation and Research; discussion planned ...

Federal appeals court overturns order blocking Avadel Pharmaceuticals from seeking FDA approval for Lumryz in idiopathic ...