Alkermes plc announced the initiation of its rolling submission of a New Drug Application to the U.S. Food and Drug Administration, seeking marketing approval of ALKS 5461. The once-daily, oral vestigational medicine with a novel mechanism of action is intended for the adjunctive treatment of major depressive disorder MDD).

Ocular Therapeutix’s NDA resubmission for DEXTENZA 0.4 mg for ocular pain occurring after ophthalmic surgery was accepted as a filing for review by FDA.

Eagle Pharmaceuticals Inc. announced that it has completed the submission of its 505(b)(2) New Drug Application for Ryanodex for the treatment of exertional heat stroke (EHS) to the U.S. Food and Drug Administration.

Vifor Fresenius Medical Care Renal Pharma obtains rights to commercialize RAYALDEE in Europe, Canada and certain other international markets; OPKO Health to receive up to $282 million in upfront and milestone payments, plus tiered double-digit royalties.

The pharma industry’s R&D concentration has been shifting towards specialty therapy areas as research and development returns decline for some leaders.

REDWOOD CITY, Calif.–(BUSINESS WIRE)–Heron Therapeutics, Inc. (NASDAQ:HRTX), announced today that the U.S. Food and Drug Administration (FDA) has informed the Company that it has not yet completed its review of […]