FDA issued CRLs for RP1 and glofitamab; CB-010 shows promise in lymphoma; osimertinib plus chemo extends NSCLC survival; and ...

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 ...

To address these challenges and achieve accurate, fast detection of insulator defects and dampers, this article proposes a novel anchor-free object detection algorithm named comprehensive ...

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

The FDA’s complete response letter cited concerns that the Phase I/II IGNYTE (NCT03767348) trial in advanced melanoma was not ...

Replimune Group, Inc. faces FDA setbacks with RP1, raising financial risks and dilution concerns. Click here to find out why ...

Replimune Group, Inc. (NASDAQ:REPL) saw its stock nosedive 77% on Tuesday after the company revealed it received a Complete ...

Vusolimogene oderparepvec is a genetically modified herpes simplex type 1 virus designed to directly destroy tumors and generate an anti-tumor immune response.

Leerink downgraded Replimune (REPL) to Market Perform from Outperform with a price target of $3, down from $21, after the FDA issued a Complete ...