FDA grants Novartis accelerated approval for Kymriah (tisagenlecleucel) for treating adult patients with relapsed or refractory follicular lymphoma af...
Federal Register notice: FDA classifies coronary artery disease risk indicators using acoustic heart signals into Class 2 (special controls).
Sens. Cassidy and Hassan call on FDA and the Patent and Trademark Office to better coordinate and communicate on drug patent applications that could d...
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...