The U.S. FDA rejected Cambridge, Massachusetts-based Akebia Therapeutics’ New Drug Application (NDA) for vadadustat, a therapeutic for anemia due to chronic kidney disease (CKD).

Ardelyx reported in a regulatory filing that the U.S. Food and Drug Administration sent an Appeal Denied Letter (ADL) for the company’s drug tenapanor, a therapeutic intended for chronic kidney disease.

After receiving a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for the New Drug Application for tenapanor for control of serum phosphorus in adults with chronic kidney disease on dialysis, Waltham, Mass.-based Ardelyx is restructuring to save money.

After the July 4 holiday, the U.S. Food and Drug Administration has several items on the regulatory agency’s immediate calendar, including a couple target action dates and an advisory committee hearing.

Novartis

Novartis will manufacture the anti-cholesterol medicine Leqvio at the company’s own plant in Austria to supply the United States as the Swiss drugmaker seeks U.S. approval that has been delayed by regulatory concerns over a contractor’s Italian facility.

Fennec Pharmaceuticals resubmitted the company’s New Drug Application (NDA) to the U.S. Food and Drug Administration for the pediatric chemotherapy-induced hearing loss prevention drug Pedmark.

Takeda’s non-small cell lung cancer (NSCLC) treatment Mobocertinib (TAK-788) is leading closer to regulatory approval after the U.S. Food and Drug Administration granted priority review to the New Drug Application. 

Shares of Supernus Pharmaceuticals climbed in trading on April 5 after the U.S. Food and Drug Administration’s April 2 approval of the company’s non-stimulant treatment for attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age.

AbbVie

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.

After a start-of-the-year lull, activities at the U.S. Food and Drug Administration are starting to pick up, according to BioSpace.