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The companies plan to file a Biologics License Application for sotrovimab with the FDA in the second half of this year, when they have the full results from the phase 3 study. Read More
In a global phase 3 study, the J&J vaccine showed overall efficacy of 66 percent and offered 100 percent protection against coronavirus-related hospitalizations and death. Read More
Amgen’s potential blockbuster cancer drug Lumakras (sotorasib) has secured the FDA’s approval for the treatment of adults with nonsmall-cell lung cancer (NSCLCs) whose tumors contain the KRAS G12C gene mutation and who have received at least one prior line of therapy. Read More
The FDA has issued a complete response letter (CRL) to Eton Pharmaceuticals over its dehydrated alcohol injection for treating methanol poisoning, saying it could not approve the company’s New Drug Application (NDA) at this time. Read More
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