Dec. 18 Quick Takes: FDA approves expanded label for Benlysta and first oral prostate cancer therapy; plus Novartis, FibroGen, A2i, China’s NRDL and more 

FDA expands Benlysta label to include lupus nephritis
FDA approved Benlysta belimumab from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) for adults with active lupus nephritis, making it the first therapy specifically approved for the systemic lupus erythematosus complication. Benlysta was approved for SLE in 2011, but lupus nephritis is treated differently and the drug’s label previously recommended against use in patients with severe active lupus nephritis. 

Myovant gains first FDA approval for oral prostate cancer therapy 
FDA approved Orgovyx relugolix from Myovant Sciences GmbH (NYSE:MYOV). It is the first oral hormone therapy for advanced prostate cancer, according to the agency...