Tag Archive for: FDA approval

The blockbuster PD-1 inhibitor’s label expanded further on Monday when the FDA greenlit Keytruda as a perioperative treatment for certain patients with earlier stages of non-small cell lung cancer.

The FDA was on a roll in the first half of 2023, approving more than two dozen novel treatments. And if the first six months is any indication, the biopharma industry should expect several more novel therapies to be greenlit, including a few more first-in-class treatments.

After two prior setbacks, the regulator has finally approved Ipsen’s palovarotene to treat fibrodysplasia ossificans progressiva. It’s the first treatment for the ultra-rare bone disease.

Following a nearly decade-long effort, Delcath Systems finally won the FDA’s greenlight for its Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma.

J&J’s Janssen Pharmaceutical got the FDA’s greenlight Friday for its PARP inhibitor Akeega, which is now authorized to treat BRCA-mutated metastatic castration-resistant prostate cancer.

The approval by the Food and Drug Administration helps Revance enter the $2.5 billion U.S. market for therapeutic neuromodulator, a method that directly acts on nerves, the company said on Monday.

The company scored a regulatory win for its geographic atrophy eye injection Izervay, just three months after the New Jersey biotech was bought by Astellas Pharma for $5.9 billion.

The biopharma company reported sales of $2.24 billion in the second quarter for the cystic fibrosis treatment, beating analysts’ estimate, after it won FDA approval in children ages two to five in April.

The treatment, branded as Vanflyta, got FDA’s nod to treat adult patients with a specific gene mutation associated with increased risk of relapse in patients with AML, a type of blood and bone marrow cancer.

The vaccine, Cyfendus, has been approved for use following suspected or confirmed exposure to a type of bacteria and has to be administered together with antibacterial drugs.