Results from the SOHO-01 trial supported expanded use of sevabertinib in adults with HER2-mutated, locally advanced or metastatic nonsquamous non–small cell lung cancer, including patients who had not...
The FDA approved Zongertinib for adults with unresectable or metastatic non-squamous NSCLC with HER2 (ERBB2) TKD activating mutations following prior systemic therapy.
The FDA has proposed new draft guidance to improve the accuracy of pulse oximeters across all skin tones, addressing long-standing concerns about potential disparities in performance.
The FDA is seeking a cap on nicotine levels in cigarettes and certain tobacco products at minimally or nonaddictive levels. This initiative, if finalized, would be what the FDA calls a “significant step”...
The FDA has approved sotatercept-csrk, the first activin signaling inhibitor therapy, for the management of patients with pulmonary arterial hypertension (PAH). Based on the Phase 3 STELLAR trial,...
Following a multicenter clinical trial, a new treatment for pneumonia caused by Acinetobacter baumannii-calcoaceticus has been approved for use in adults.
Following three clinical trials, the FDA has approved a new preventive treatment for neonates, infants, and toddlers that prevents respiratory syncytial virus (RSV) in those age populations.
Following a multicenter study, the FDA approved the combination of albuterol and budesonide—an inhaled corticosteroid—for the treatment of asthma in adults.
It is a new indication for the medication, which had already been FDA-approved for the treatment of patients with complicated UTIs and complicated intraabdominal infections who have limited or no...
