Waiting In The Wings: Novel Agents In Line For FDA Action By Year-End
Executive Summary
An interactive chart of new molecular entities and novel biologics with user fee goals in the second half of 2015.
You may also be interested in...
Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa
The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.
Change Is Constant For Pneumococcal Vaccines: US CDC Prepares For Merck’s V116
As Merck’s 21-valent vaccine approaches its 17 June user fee goal, the US CDC’s vaccine committee is looking at new adult age-based recommendations and bracing for a full pipeline led by GSK’s 24-valent candidate.
US FDA Expects Joint AdComm Briefing Document, Oncology Chief Says
The combined format is the new default for briefing advisory committee members, US FDA Oncology Center of Excellence Director Pazdur declared.