Topic: FDA application process
AstraZeneca landed the PDUFA date for [fam-] trastuzumab deruxtecan after the FDA accepted its approval submission for priority review.
The FDA plans to increase the number of clinical offices and divisions and group them by therapeutic area.
Merck has a shot at becoming the first company to receive clearance to sell a vaccine against the virus in the U.S.
Sanofi will learn whether the FDA will approve anti-CD38 antibody isatuximab in multiple myeloma by the end of April 2020.
The FDA has quashed ImmunoGen’s hopes of filing for approval of mirvetuximab soravtansine on the strength of a failed phase 3.
The FDA has begun to reconsider how it reviews and approves devices that employ artificial intelligence and to learn from data to adapt their care.
The agency said it has begun implementing three recommendations from HHS to fully integrate cybersecurity requirements into its premarket reviews.
The FDA has rejected Vernalis’ filing for approval of CCP-08, scuttling its hopes of coming to market in time for the 2017-18 cough-cold season.
Officials knocked back the filing after phase 3 data linked the sclerostin-targeting antibody to an increased risk of cardiovascular adverse events.
Shares in Puma Biotechnology jumped 40% after the FDA trod lightly around doubts about its filing for approval of breast cancer drug neratinib.