Phathom Pharmaceuticals Inc. submitted two new drug applications (NDAs) to the U.S. Food and Drug Administration for the use of vonoprazan in combination with amoxicillin and clarithromycin (vonoprazan triple therapy) and vonoprazan in combination with amoxicillin (vonoprazan dual therapy) as a treatment for Helicobacter pylori infection in adults.
After discussions with the U.S. Food and Drug Administration, Paris-based Ipsen withdrew the company’s New Drug Application (NDA) for palovarotene.
Gilead Sciences is aiming to win regulatory approval for the first HIV-1 treatment administered twice per year as the company submitted a New Drug Application to the U.S. Food and Drug Administration for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor.
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.