Sarfez Pharmaceuticals announced approval by the U.S. Food and Drug Administration of the Virginia-based company’s New Drug Application for Soaanz, a once-a-day improved formulation of the loop diuretic torsemide.
United Therapeutics Corporation announced that the company is pursuing additional claims for trade secret misappropriation against Liquidia Technologies Inc. and a former United Therapeutics employee who later joined Liquidia as an executive.
Ipsen’s New Drug Application (NDA) for palovarotene – an oral, investigational, selective RARγ agonist for the prevention of heterotopic ossification (new bone formation) as a potential treatment option for people living with the progressive disabling and ultra-rare genetic disorder fibrodysplasia ossificans progressiva (FOP) – was accepted by the U.S. Food and Drug Administration.
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.