Food and Drug Administration (FDA)
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The CRL is not totally unexpected, given that last month the company received a multi-disciplinary review (DR) letter from the FDA regarding its New Drug Application.
The U.S. Food and Drug Administration (FDA) approved ADMA Biologics’ Asceniv to treat Primary Humoral Immunodeficiency Disease (PIDD or PI) in adults and adolescents.
The investigational therapeutic umbralisib, which targets the molecule PI3K- delta, was well tolerated and highly active in patients with relapsed/refractory marginal zone lymphoma, according to early results from the UNITY-NHL phase II clinical trial, which were presented at the AACR Annual Meeting 2019, March 29–April 3.
The late-stage studies funded by the financing round could set the stage for two potential regulatory approvals if the data remains strong.
EMD Serono, a unit of Merck KGaA, Darmstadt, Germany, announced that the U.S. Food and Drug Administration (FDA) had approved Mavenclad (cladribine) for adults with relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive disease (SPMS).
There are three companies looking for decisions by the U.S. Food and Drug Administration (FDA) this week. All three drugs are either resubmissions or have had to deal with various problems related to manufacturing or incomplete data. Here’s a look.
Cambridge, Mass.-based Sarepta Therapeutics announced data from its interim analysis of muscle biopsy endpoints of its therapy casimersen for Duchenne muscular dystrophy (DMD). The interim data was strong enough to support a probable New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) by mid-year.
Gottlieb said the FDA believes there should be a premarket demonstration that a new opioid is superior to an already-approved opioid.
Novartis will quickly roll Mayzent out to U.S. physicians. The Swiss pharma giant plans to make the drug available within one week of the FDA approval.
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