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 ...

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

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.

Iova stock jumps 31% amid FDA setback for rival, short squeeze buzz, and rising momentum for Amtagvi melanoma therapy.

Replimune (REPL) stock rebounds even as FDA rejection of its RP1 skin cancer drug lead to multiple analyst downgrades on Wall Street. Read more here.

Replimune's RP1 treatment for advanced melanoma faces FDA rejection due to trial design issues, despite promising results ...

Replimune stock cratered Tuesday after the Food and Drug Administration unexpectedly rejected its experimental melanoma ...

Replimune stock (ticker: REPL) cratered on Tuesday after the biotech said the U.S. Food and Drug Administration rejected an ...