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Merck has hit another snag as it seeks a new breast cancer indication for its blockbuster oncology drug Keytruda — a Complete Response Letter (CRL) from the FDA seeking more supporting evidence for its supplemental Biologics License Application (sBLA). Read More
Humanigen said it will seek an FDA Emergency Use Authorization for its monoclonal antibody lenzilumab “as soon as possible” based on positive results from a phase 3 clinical trial that showed the drug significantly reduced the risk of death for hospitalized COVID-19 patients. Read More
The FDA has granted approval for Bristol Myers Squibb’s and bluebird bio’s personalized immune-cell therapy Abecma (idecabtagene vicleucel; ide-cel) for multiple myeloma in adults, marking the first chimeric antigen receptor (CAR) T-cell therapy for the plasma-cell cancer. Read More
Myrbetriq was previously approved for treating overactive bladders in adults, but Myrbetriq Granules do not currently have a recommended adult dosage. Read More
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