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 ...

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 ...

The CRL was given because the FDA did not consider the phase 1/2 IGNYTE trial to be an adequate and well-controlled clinical ...

The latest details of Indonesian Vice President Gibran Rakabuming Raka's assets show a Rp1.9 billion increase.

The Corruption Eradication Commission (KPK) has released the Wealth Report of State Officials (LHKPN) for President Prabowo ...

In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...

The FDA has decided not to approve vusolimogene oderparepvec (RP1) in combination with nivolumab for advanced melanoma.

Why: Rosen Law Firm, a global investor rights law firm, announces an investigation of potential securities claims on behalf ...