G1 Therapeutics Inc.
Please contact Sales at: (212) 520-2765 or email PharmaNewsSales@informa.com
Latest From G1 Therapeutics Inc.
Keeping Track: Jardiance Approved Across Heart Failure Spectrum, But US FDA Turns Down Bardoxolone, Terlipressin
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
CDER hit a high mark with 27 first-in-class approvals in the 50 novel agents cleared in 2021.
Sweden’s Xbrane Biopharma has secured a manufacturing partner in its native Scandinavia, Denmark’s AGC Biologics, to help complete key steps for its proposed Xcimzane (certolizumab pegol) biosimilar to Cimzia ahead of Phase I and Phase III clinical trials.
Provention has been working hard collecting necessary data for a potential BLA resubmission for teplizumab in patients at risk of developing type 1 diabetes after receiving a complete response letter in July. Hopes rest on a Type A meeting with the FDA in Q4.