The U.S. Food and Drug Administration approved Rhythm Pharmaceuticals’ Imcivree (setmelanotide) for chronic weight management in adult and pediatric patients aged 6 years and older with obesity due to proopiomelanocortin, proprotein convertase subtilisin/kexin type 1 or leptin receptor deficiency confirmed by genetic testing.
The U.S. Food and Drug Administration’s PDUFA dates for the last week of November 2020 include a review of Liquidia Technologies’ NDA for LIQ861 for the treatment of pulmonary arterial hypertension (PAH).
Treatments for peanut allergy and Parkinson’s disease are among U.S. drug launches that have been postponed by the COVID-19 pandemic as drugmakers struggle with disruptions to business, a Reuters review of filings and interviews with executives show.
The U.S. Food and Drug Administration gave the green light to Sanofi’s Sarclisa (isatuximab-irfc) in combination with pomalidomide and dexamethasone (pom-dex) for adults with multiple myeloma who have had two previous therapies including lenalidomide and a protease inhibitor.
GlaxoSmithKline CEO Emma Walmsley is anticipating a good 2020 for her company, with the potential of six regulatory approvals in the United States.
Forty-eight new molecular entities and new therapeutic biological products were approved by the U.S. regulatory agency’s Center for Drug Evaluation and Research (CDER) in 2019.