After discussions with the U.S. Food and Drug Administration, Paris-based Ipsen withdrew the company’s New Drug Application (NDA) for palovarotene.

The Phase 3 KEYNOTE-716 trial investigating Merck’s anti-PD-1 therapy Keytruda met its primary endpoint of recurrence-free survival (RFS) for the adjuvant treatment of patients with surgically resected high-risk stage II melanoma.

The United States Food and Drugs Administration granted a priority review for Roche’s Tecentriq treatment for people suffering with early, non-small-cell lung cancer, the Swiss company said on Aug. 3.

The U.S. Food and Drug Administration greenlit AstraZeneca’s Farxiga (dapagliflozin) under priority review for the treatment of chronic kidney disease in patients at risk of progression with or without type 2 diabetes.

The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee did not agree in a meeting to maintain the accelerated approval of Bristol Myers Squibb’s Opdivo (nivolumab) as a second-line treatment of hepatocellular carcinoma.

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. 

The U.S. Food and Drug Administration approved Merck & Co. and Bayer AG’s heart failure drug Verquvo (vericiguat), an orally administered soluble guanylate cyclase stimulator.

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

The U.S. Food and Drug Administration (FDA) approved Alnylam Pharmaceuticals’ Oxlumo (lumasiran) for primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in children and adults.

The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) for Sanofi’s blood cancer treatment sutimlimab.