Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...

TEMPO.CO, Jakarta - The number of people living in poverty in South Sumatra, Indonesia, has decreased dramatically over the ...

Many companies face FDA complete response letters due to ongoing chemistry, manufacturing, and controls, or CMC, and ...

Bristol Myers Squibb acknowledged that a phase III trial of luspatercept (Reblozyl) plus a Janus kinase inhibitor for ...