box, layoffs

Spero Therapeutics is laying off approximately 75 percent of the company’s workforce as part of a restructuring operation in light of the U.S. Food and Drug Administration’s expected rejection of Spero’s New Drug Application (NDA) for bacterial diseases. 

FDA sign

China-based Hutchmed failed to get the U.S. Food and Drug Administration’s approval for the company’s proposed drug for pancreatic cancer.

Six members of the U.S. Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee voted not to approve Amylyx Pharmaceuticals’ new drug application (NDA) for the company’s amyotrophic lateral sclerosis (ALS) candidate AMX0035, while four voted yes.

Taiho Oncology Inc. and Taiho Pharmaceutical Co. Ltd. announced that the U.S. Food and Drug Administration accepted for priority review the New Drug Application (NDA) for futibatinib in the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring FGFR2 gene rearrangements, including gene fusions.

Travere Therapeutics Inc. submitted a New Drug Application to the U.S. Food and Drug Administration under Subpart H for accelerated approval of sparsentan for the treatment of IgA nephropathy (IgAN).

According to a filing with the U.S. Security and Exchange Commission, FibroGen is tangled up in a Securities Class Action Litigation as well as Derivative Litigation regarding clinical trial data for the company’s drug Roxadustat, which is being developed with AstraZeneca and Astellas.

The U.S. Food and Drug Administration rejected Reata Pharmaceuticals’ New Drug Application for the company’s proposed chronic kidney disease drug, citing a lack of proof of effectiveness. 

FDA

The U.S. Food and Drug Administration held a joint meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee on Avenue Therapeutics’ IV tramadol. 

Incyte Corporation withdrew the New Drug Application (NDA) for the company’s candidate drug for various types of lymphoma.

The U.S. Food and Drug Administration issued a Complete Response Letter to Merck & Co. for the company’s New Drug Application for gefapixant for refractory chronic cough or unexplained chronic cough.