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The FDA has approved Myovant Sciences’ and Pfizer’s estrogen-based hormone therapy, Myfembree, for the treatment of heavy menstrual bleeding associated with uterine fibroids, the first once-daily regimen for the condition, according to the companies. Read More
GlaxoSmithKline’s (GSK) and Vir Biotechnology’s monoclonal antibody sotrovimab has secured FDA Emergency Use Authorization (EUA) for treating mild-to-moderate COVID-19 in patients 12 years and older at high risk of progressing to severe disease. Read More
The approval was supported by a study enrolling 81 patients whose disease had progressed during or after treatment with platinum-based chemotherapy, the agency said. Read More
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has voiced support for approving Sanofi’s and Regeneron’s monoclonal antibody Libtayo (cemiplimab) for advanced nonsmall-cell lung cancer (NSCLC) and advanced basal cell carcinoma. Read More
For the first time, the FDA has approved a treatment for adult nonsmall-cell lung cancer (NSCLC) patients with a specific type of genetic mutation, giving Johnson & Johnson (J&J)’s Rybrevant the green light Friday. Read More
The FDA has approved Bristol Myers Squibb’s blockbuster oncology drug Opdivo (nivolumab) for the treatment of patients with completely resected esophageal or gastroesophageal junction cancer who have residual pathologic disease and have received neoadjuvant chemoradiotherapy — making it the first immunotherapy to receive the agency’s blessing for this indication. Read More
The FDA has begun its review of Innovent Biologics’ and Eli Lilly’s biologics license application (BLA) for sintilimab, a PD-1 inhibitor for the first-line treatment of nonsquamous nonsmall-cell lung cancer (NSCLC) alongside chemotherapy. Read More