OLOROFIM in a TIGHT SPOT
Regulatory and development status of Olorofim, a novel antifungal. Continue reading OLOROFIM in a TIGHT SPOT
Tag Archives: CRL
Sulopenem uUTI – Does It Suffice?
Sulopenem / ORLYNVAH approved for uUTI When Iterum, a Pfizer spin-off of sorts, took over sulopenem development in 2015, there was still hope for approvals of this drug in multiple indications such as uUTI, cUTI, cIAI and even CABP. Ten Continue reading Sulopenem uUTI – Does It Suffice?
Omissions – Commissions – Errors – Blunders – Solithromycin
Cempra received a complete response letter (CRL) as a X-mas present from FDA, and the news was pretty bad for company investors. Bad, but not totally unexpected after the AMDAC meeting last November, which taught us a few new things Continue reading Omissions – Commissions – Errors – Blunders – Solithromycin