1. Epizyme’s Tazverik (tazemetostat) Receives the US FDA’s Accelerated Approval as the First Therapy for Epithelioid Sarcoma Published: Jan 23, 2020 | Tags: Epizyme, Tazverik, tazemetostat, Receives, US, FDA, Accelerated Approval, […]readmore
Tags : TB Alliance
Shots: Hongqi to get a license to commercialize pretomanid as part of the three-drug “BPaL” regimen to treat a highly drug-resistant form of tuberculosis in People’s Republic of China The […]readmore
The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 31 new products so far in 2019. In 2018 FDA […]readmore
Shots: The approval is based on the Nix-TB trial assessing bedaquiline, pretomanid and linezolid collectively called BPaL regimen in 109 patients with XDR-TB treatment-intolerant or non-responsive MDR-TB across three sites […]readmore
Shots: Mylan to get manufacturing & commercialization rights of pretomanid in BPaL regimen (bedaquiline, pretomanid and linezolid for 6-9 mos.) for XDR & MDR-TB. Janssen to hold the rights for […]readmore