Several biopharmaceutical companies submitted New Drug Applications (NDAs) to the U.S. Food and Drug Administration in recent weeks, covering treatment indications ranging from an opioid overdose to bipolar disorder and rare disease.
France-based Genfit launched NASHnext, a novel, non-invasive diagnostic test for nonalcoholic steatohepatitis (NASH) powered by the company’s proprietary diagnostic technology, NIS4. The test is offered in the United States through Labcorp.
Shares of FibroGen were down after the company unsuccessfully attempted to express confidence in the benefit/risk profile of its anemia drug roxadustat.
The U.S. Food and Drug Administration accepted AbbVie’s New Drug Application for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist for the preventive treatment of migraine in adults who meet criteria for episodic migraine.
Oyster Point’s New Drug Application (NDA) for the dry eye disease therapy OC-01 was accepted for FDA regulatory review on the back of positive Phase III data.
The U.S. Food and Drug Administration decided to put together an advisory committee meeting of outside experts to review a New Drug Application (NDA) for FibroGen and partner AstraZeneca’s investigational anemia therapy roxadustat.
Novo Nordisk is positioning the company’s type 2 diabetes treatment Ozempic (semaglutide) as an anti-obesity treatment, as data published in the New England Journal of Medicine shows the once-weekly dose of the glucagon-like peptide-1 analog significantly reduced weight in patients over the course of 68 weeks.
AstraZeneca spinout Albireo Pharma is moving closer to securing regulatory approval for the company’s treatment of pruritus in patients with progressive familial intrahepatic cholestasis (PFIC).
The U.S. Food and Drug Administration approved ViiV Healthcare’s Cabenuva as the only complete long-acting regimen for the treatment of HIV-1 infection in adults.
The U.S. Food and Drug Administration accepted for review Impel NeuroPharma’s 5O5(b)(2) New Drug Application (NDA) for INP104 for the acute treatment of migraine headaches with or without aura in adults.