The latest drug development news and highlights from our FDA Performance Tracker.
FDA accepted applications for two more novel products as the agency's 2017 user fee calendar continues to fill. Here's your news in brief:
Pfizer Inc.'s inotuzumab ozogamicin and The Medicines Co.'s Carbavance (meropenem/vaborbactam) join more than 40 other new molecular entities and novel biologics under review at the agency
The Oncologic Drugs Advisory Committee will meet for two days in mid-May, followed by a Vaccines and Related Biological Products Advisory Committee’s review of the 2025-2026 COVID-19 vaccine formulation.
The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.
Some advisory committee members said adding quantitative data on misuse, abuse, opioid use disorder and overdose to labeling would be helpful, but others worried the two epidemiological studies were not sufficiently generalizable to a broader population.
