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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
Tecentriq “continues to demonstrate benefits across multiple cancer types and therefore remains a meaningful treatment option for many patients,” Roche said. Read More
The FDA’s Oncology Center for Excellence is scrutinizing Accelerated Approvals granted for cancer indications in an initiative that’s led to multiple indication withdrawals by companies whose late-stage trials failed to meet primary endpoints. Read More