Drug

The FDA has accepted a new drug application for daprodustat, which was filed by GlaxoSmithKline plc, according to a press release.

BOSTON — New research presented during the late-breaking trials program at the National Kidney Foundation Spring Clinical Meetings showed the anemia drug daprodustat has cardiovascular benefits comparable to erythropoiesis-stimulating agents.

The FDA rejected Akebia Therapeutics’ anemia drug vadadustat for use in patients with chronic kidney disease, citing concerns about vascular access complications and liver toxicity.

The combination of MDMA and psychotherapy improved PTSD symptoms among participants in a phase 3 clinical trial, researchers reported at the spring meeting of the American Chemical Society.

The long-term use of IV edaravone in patients with ALS, although tolerated, did not produce significant improvement compared with standard therapies alone, according to a study published in JAMA Neurology.

The FDA has granted priority review to PTC Therapeutics Inc. for a supplemental new drug application regarding Evrysdi, according to a company release.

Clinical-stage biotech developer ABL Bio Inc. announced it will collaborate and enter a worldwide license agreement with Sanofi to develop and commercialize a treatment for Parkinson’s disease and other potential indications.

The FDA has approved the supplemental new drug application for Rexulti for treating schizophrenia in patients aged 13 to 17 years, Otsuka and Lundbeck announced.

The FDA granted orphan drug exclusivity for JZP258, an oral low-sodium oxybate solution for the treatment of idiopathic hypersomnia in adults, according to Jazz Pharmaceuticals.

Cara Therapeutics Inc. announced that Korsuva injection received CMS transitional drug add-on payment adjustment in the anti-pruritic functional category.