Shares of Applied Therapeutics plunged in premarket trading on January 3 after the company announced it is unable to seek regulatory approval of the Galactosemia therapeutic AT-007 at this time.
Shares of Takeda Pharmaceutical fell after the company announced the U.S. Food and Drug Administration rejected the New Drug Application for TAK-721 (budesonide oral suspension) for the treatment of eosinophilic esophagitis.
Almost one year after Biogen forged a collaboration with Sage Therapeutics worth $1.52 billion, the development deal for the experimental major depressive disorder treatment zuranolone is bearing fruit that will support an expected rolling New Drug Application during 2022.
Two years after spinning out from Japan’s Takeda, Phathom Pharmaceuticals is primed to take the company’s acid blocker to the U.S. market with another successful trial.
The U.S. Food and Drug Administration did not approve Polarean Imaging’s application for a new drug-device combination product, sending the company’s shares tumbling 60 percent.
The U.S. Food and Drug Administration accepted for filing the New Drug Application submitted by Acer Therapeutics Inc. and the company’s collaboration partner Relief Therapeutics Holding SA for ACER-001 (sodium phenylbutyrate) for the treatment of patients with Urea Cycle Disorders.
Mike Hidock, Director of Quality and Compliance Services at IQVIA, analyzes key considerations for preparing quality management systems (QMS) for fast tracked COVID-19 treatment approvals.
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.