We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
GlaxoSmithKline (GSK) and Vir Biotechnology have filed for Emergency Use Authorization (EUA) for their SARS-CoV-2 monoclonal antibody ahead of schedule, having recently stopped their phase 3 trial after seeing significantly positive results. Read More
The FDA has approved Merck’s blockbuster cancer drug Keytruda (pembrolizumab) for certain patients with esophageal or gastroesophageal cancer taken in combination with platinum and fluoropyrimidine-based chemotherapy. Read More
The UK’s National Institute for Health and Care Excellence (NICE) has decided it will not fund Keytruda (pembrolizumab), Merck’s second-line advanced bladder cancer drug. Read More
The FDA approved 17 original abbreviated new drug applications (ANDAs) in the third quarter of fiscal 2020, 14 in the fourth quarter and 18 in the first quarter of fiscal 2021. It’s seen a downward trend in manufacturing supplements for new drug applications (NDAs), biologics license applications (BLAs) and ANDAs, approving 314 in the third quarter of fiscal 2020, 277 in the fourth quarter and 149 in the first quarter of this fiscal year. Read More
The FDA has extended its review period for AbbVie’s supplemental New Drug Application (sNDA) for Rinvoq (upadacitinib) as a treatment for adults with psoriatic arthritis. Read More
The single-dose J&J vaccine “takes us another step closer to achieving our collective goal of vaccinating 70 percent of the adult population by the end of summer,” said the commission’s president, Ursula von der Leyen. Read More
The World Health Organization (WHO) issued an Emergency Use Listing on Friday for Johnson & Johnson’s one-shot COVID-19 vaccine — a step that clears the way for the COVAX global vaccine-sharing program to begin distributing the shot to poorer countries hardest hit by the pandemic. Read More
AstraZeneca (AZ) could be ready to request Emergency Use Authorization (EUA) from the FDA for its COVID-19 vaccine before the end of the month as its U.S. phase 3 trial nears having enough data to adequately assess its efficacy. Read More