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The UK’s National Institute for Clinical Excellence (NICE) voted down a recommendation for Gilead Sciences’ chemotherapy drug aimed at triple-negative breast cancer, but approved Merck KGaA’s Bavencio (avelumab), which fought its way back into the agency’s good graces after stakeholders launched a letter-writing campaign and the company lowered its cost. Read More
HHS and the FDA have expanded the list of states where GlaxoSmithKline’s and Vir Biotechnology’s COVID-19 monoclonal antibody, sotrovimab, may not be used due to concerns about the treatment’s efficacy against the Omicron subvariant BA.2. Read More
The FDA has approved Kite’s Yescarta (axicabtagene ciloleucel) drug for a new indication — initial treatment for patients with relapsed or refractory large B-cell lymphoma (LBCL), which its parents company Gilead said is the first chimeric antigen receptor (CAR) T-cell therapy to have done so. Read More
The European Medicines Agency’s (EMA) human medicines committee endorsed five new medicines — including a COVID-19 treatment and a gene therapy — during its monthly meeting held from March 21 to 24. Read More