Atai Life Sciences and its partner Recognify Life Sciences said on Friday their experimental drug did not meet the main goal in a mid-stage trial for patients with schizophrenia-linked cognitive ...

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.

The strategic reprioritization comes after the company hit two major hurdles in the past year, including a clinical hold 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 ...

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.

The U.S. Food & Drug Administration (FDA) has approved certain GLP-1 drugs for commercialization and use, including liraglutide ...

Replimune Group, Inc – a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies – ...

Landmark trials have shown that GLP-1 receptor agonists, originally developed for diabetes and weight loss, also provide ...

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

The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license ...