A look at the U.S. Food and Drug Administration’s drug approval review calendar.
Despite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here is a look at what is on the schedule for the next two weeks.
The U.S. Food and Drug Administration has a busy week of possible drug approvals on the regulatory agency’s calendar, including Celgene’s ozanimod for relapsing forms of multiple sclerosis.
The collaboration will utilize EVERSANA’s integrated suite of outsourced services to commercialize and distribute Evoke Pharma Inc.’s Gimoti in the United States.
Eton Pharmaceuticals Inc. announced that Aucta Pharmaceuticals Inc.’s New Drug Application for ET-105, an innovative formulation of lamotrigine which Eton acquired the U.S. marketing rights to in June 2019, was accepted for review by the U.S. Food and Drug Administration.
Intra-Cellular Therapies shares fell after the company announced that the FDA canceled the advisory committee meeting to discuss the New Drug Application for the schizophrenia drug lumateperone.
New interim data from the ongoing open-label, pivotal EVOLVE-MS-1 study indicate that Biogen’s investigational treatment diroximel fumarate was generally well tolerated in people with relapsing MS.
With an opioid molecule awaiting regulatory review, Nektar Therapeutics announced the launch of Inheris Biopharma, which will be responsible for the commercialization of NKTR-181.
Kala Pharmaceuticals Inc. announced that the New Drug Application (NDA) for KPI-121 0.25%, a product candidate for the temporary relief of signs and symptoms of dry eye disease utilizing a two-week course of therapy, has been accepted for review by the United States Food and Drug Administration FDA.
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.