The U.S. Food and Drug Administration approved a new indication for GlaxoSmithKline plc and Innoviva Inc.’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to the product’s current license for use in patients with chronic obstructive pulmonary disease (COPD).
Russia became the first country to grant regulatory approval to a Covid-19 vaccine, after less than two months of human testing.
U.S. Food and Drug Administration PDUFA dates on the calendar for July include an NDA review for Jazz Pharmaceuticals’ experimental medicine for cataplexy.
The U.S. Food and Drug Administration approved Bavencio (avelumab) for maintenance treatment of locally advanced or metastatic urothelial carcinoma that has not progressed after first-line platinum-containing chemotherapy.
Treatments for peanut allergy and Parkinson’s disease are among U.S. drug launches that have been postponed by the COVID-19 pandemic as drugmakers struggle with disruptions to business, a Reuters review of filings and interviews with executives show.
The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
The U.S. Food and Drug Administration approved Merck’s anti-PD-1 therapy Keytruda as monotherapy for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
The U.S. Food and Drug Administration greenlit Karyopharm Therapeutics’ Xpovio (selinexor) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) under accelerated approval.
The U.S. Food and Drug Administration approved Novartis’ Cosentyx (secukinumab) for the treatment of active non-radiographic axial spondyloarthritis.
The U.S. Food and Drug Administration approved an expanded indication for Merck’s GARDASIL 9 for the prevention of oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58.
