Researchers say CMS too often pays for drugs that received FDA accelerated approval but did not confirm a clinical benefit.
FDA removes a clinical hold against a Legend Biotech Phase 1 clinical trial of LB1901, an investigational autologous chimeric antigen receptor T-cell ...
FDA clears a Stryker 510(k) for its Q Guidance System for advanced planning and intraoperative guidance during open or percutaneous computer-assisted ...
FDA denies most elements in four Consumers for Dental Choice petitions seeking additional agency actions to stop or reduce amalgam use in dentistry.
FDA approves two indications involving Bristol-Myers Squibbs Opdivo in combination with other drugs for some esophageal cancers.
FDA places a clinical hold on a Sanofi actual use trial to support its planned Rx-to-OTC switch for Cialis (tadalafil), which it licensed from Eli Lil...
BioMarin Pharmaceutical plans to resubmit a BLA for valoctocogene roxaparvovec, a gene therapy for severe hemophilia A, by the end of September that w...
FDA extends by three months its review of a TG Therapeutics BLA for ublituximab, indicated for treating patients with relapsing forms of multiple scle...