The U.S. Food and Drug Administration accepted for review Orion and Bayer’s New Drug Application for darolutamide for the treatment of non-metastatic castration-resistant prostate cancer.

Johnson & Johnson’s drug Balversa won U.S. approval as the first targeted therapy for advanced bladder cancer, the Food and Drug Administration announced.

Swiss drugmaker Roche Holding AG’s U.S. unit Genentech Inc. won approval for the immunotherapy Tecentriq for a tough-to-treat type of lung cancer.

The U.S. FDA granted Priority Review for Eli Lilly’s supplemental BLA for Emgality (galcanezumab-gnlm) injection for the preventive treatment of episodic cluster headache in adults.

Bristol-Myers Squibb Company announced the U.S. Food and Drug Administration expanded the indication for Sprycel tablets to include the treatment of pediatric patients 1 year of age and older with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy.

The U.S. Food and Drug Administration accepted for review Acer Therapeutics Inc.’s New Drug Application for Edsivo for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen mutation.

Alexion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration accepted for review the company’s Biologics License Application for approval of ALXN1210, an investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria.

The FDA approved Azedra injection for intravenous use for treating patients age 12 and older with rare tumors of the adrenal gland that cannot be surgically removed, have spread beyond the original tumor site and require systemic anticancer therapy.

The U.S. FDA approved TPOXX (tecovirimat), the first drug with an indication for the treatment of smallpox.

Astellas Pharma Inc. and Pfizer Inc. announced the U.S. FDA approved a supplemental New Drug Application for Xtandi (enzalutamide), following FDA Priority Review designation.