Keeping Track Of US FDA Decisions: Approvals For Ongentys And New Keytruda, Darzalex Dosing, But Not For Trevyent

The US FDA’s oncology divisions continue to issue fast approvals, both under the Real-Time Oncology Review pilot program and in response to pressures caused by the coronavirus pandemic. This week, Merck & Co. Inc.’s Keytruda, Johnson & Johnson’s Darzalex Faspro, and GlaxoSmithKline PLC’s Zejula all benefited.

Neurocrine Biosciences Inc.’s Parkinson’s disease therapy Ongentys became the 16th novel agent approved by the FDA’s Center for Drug...