Shares of Iterum Therapeutics plunged on July 26 after the U.S. Food and Drug Administration rejected the company’s New Drug Application for oral sulopenem as a potential treatment for uncomplicated urinary tract infections (uUTI) in patients with a quinolone non-susceptible pathogen.
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 approved Eli Lilly and Co.’s Reyvow, representing the first new class of acute migraine treatment approved by the regulatory agency in more than two decades.
The U.S. Food and Drug Administration approved Fera’s New Drug Application for Avaclyr (acyclovir ophthalmic ointment) 3% for the treatment of herpetic keratitis.
The U.S. FDA approved the New Drug Application of Xelpros 0.005% for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
The U.S. Food and Drug Administration rejected Allergan’s New Drug Application for ulipristal acetate.
GlaxoSmithKline is on track to file its three-in-one inhaled lung drug for U.S. approval by the end of 2016 rather than during first-half 2018 as initially planned.
November 18, 2015By Mark Terry, BioSpace.com Breaking News Staff Waltham, Mass.-based Radius Health, Inc. (RDUS), announced yesterday that it has sent a Marketing Authorization Application (MAA) to European regulatory agencies for its abaloparatide-SC for postmenopausal osteoporosis. At the same time, the company indicated that it is delaying its New Drug Application (NDA) to the […]
China has signaled a tougher stance on drug quality in the country’s sprawling pharmaceuticals industry by rejecting applications for 11 medicines with inadequate or suspect clinical data. The China Food and Drug Administration (CFDA) said in statement posted on its website on Nov. 11 that the move affected eight Chinese companies making generic drugs for […]