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Alkermes and Biogen Announce Submission of a New Drug Application to U.S. Food and Drug Administration for Diroximel Fumarate in Multiple Sclerosis drugs
December 26, 2018
Alkermes plc (Nasdaq: ALKS) and Biogen Inc. (Nasdaq: BIIB) today announced that Alkermes has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ....
Recro Pharma Amends IV Meloxicam License Agreement with Alkermes pharmafocusasia
December 24, 2018
Recro Pharma, Inc., a revenue generating specialty pharmaceutical company focused on therapeutics for the hospital and other acute care settings, today announced an amendment to ...
Alkermes/Biogen hope for less tummy trouble with new MS pill pharmaphorum
December 19, 2018
Alkermes and Biogen have filed a new multiple sclerosis pill with the FDA, which they hope will treat the disease with fewer unpleasant gastrointestinal side effects than the big pharma’s older MS drug, Tecfidera.
Alkermes and Biogen announce new MS drug application for FDA pharmatimes
December 19, 2018
Alkermes and Biogen have announced that Alkermes has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for diroximel fumarate.
Alkermes, Biogen Submits NDA for Diroximel Fumarate americanpharmaceuticalreview
December 18, 2018
Alkermes and Biogen announced Alkermes has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for diroximel fumarate (BIIB098).....
FDA panel backs Sage’s novel antidepressant but turns down Alkermes’ pharmaphorum
December 14, 2018
Sage’s Zulresso (brexanolone) is on course for approval for postnatal depression in the US after a positive vote from an FDA advisory committee at its meeting last week, but the same panel had bad news for Alkermes’ two-drug therapy....
Alkermes preps filing for weight-friendly schizophrenia drug pharmaphorum
November 30, 2018
Alkermes is planning to head to the FDA next year with a new schizophrenia drug that, according to phase III data, could sidestep one of the main side effects of other drugs......
Committee advises against FDA approval of Alkermes' novel depression drug pharmafile
November 19, 2018
Alkermes has been knocked back with the disappointing, though not entirely unexpected, news that the FDA-appointed Psychopharmacologic Drugs Advisory
FDA advisors turn down Alkermes’ ALKS 5461 pharmatimes
November 05, 2018
Alkermes’ ALKS 5461 has been hit with a potential setback in the US after regulatory advisors failed to back its approval for major depressive disorder (MDD).
Alkermes Initiates Evaluation of ALKS 4230 in Combination with Pembrolizumab americanpharmaceuticalreview
September 11, 2018
Alkermes has expanded its ongoing phase 1 study for ALKS 4230, the company's immuno-oncology drug candidate, to evaluate its safety and anti-tumor activity when administered in combination with the FDA-approved PD-1 inhibitor Keytruda (pembrolizumab) in p

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