The U.S. FDA approved an expanded label for Merck’s anti-PD-1 therapy Keytruda in combination with Alimta (pemetrexed) and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations, based on results of the KEYNOTE-189 trial.
Days after rejecting Regeneron’s attempt to secure a supplemental approval for Eylea, the FDA approved a new dosing label for the drug in wet age-related macular degeneration (wet AMD).
Novartis announced that the FDA approved the inclusion of Treatment-free Remission data in the Tasigna (nilotinib) U. S. product label.
Amgen Inc. can now promote the ability of the company’s potent but expensive cholesterol drug to reduce the risk of heart attacks and strokes.
The FDA approved updated labeling for Gilead Sciences’ chronic hepatitis C virus drug Epclusa to include use in patients co-infected with HIV.
Novartis said the Committee for Medicinal Products for Human Use approved a label update for Cosentyx (secukinumab), the first interleukin-17A approved to treat psoriasis.