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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
The drug is approved for adults who are treatment-naïve and for those changing regimens from Alexion Pharmaceuticals’ Soliris (eculizumab) and Ultomiris (ravulizumab). Read More
The trial will evaluate ProTcell’s ability to rapidly generate T cells in patients to reduce infections, Graft-versus-host disease and one-year non-relapse mortality. Read More
The FDA has approved Smart Immune’s investigational new drug (IND) application for ProTcell, a T cell progenitor-based biotherapy candidate, marking the first time the agency has cleared a product of its kind to enter clinical trials. Read More