Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic ...

Replimune (REPL) stock plummets as report suggests FDA’s top regulator of cancer drugs intervened in rejecting its lead asset ...

Replimune stock falls as FDA denies skin cancer drug approval and investors sue over alleged misstatements tied to the IGNYTE ...

The FDA's top regulator of cancer drugs played a key role in the rejection of a skin cancer therapy from Replimune Group, ...

The rejection occurred amid broader turmoil at the FDA, which has been experiencing leadership changes, staff upheaval, and internal dysfunction. These organizational issues reportedly factored into ...

The amount of frozen funds could be as high as $200 million, or potentially more than $300 million, according to two ...

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

One of the most notable accomplishments of the first Trump Administration was its willingness to take on the status quo of ...

Replimune (NASDAQ:REPL) stock surges as Cantor Fitzgerald upgrades, citing improved odds for approval of its lead drug after an FDA leadership change. Read more here.

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.

Following a complete response letter rejecting accelerated approval for RP1 in advanced melanoma, IGNYTE trial investigators are urging the FDA to reevaluate the therapy’s robust survival data, just ...

The FDA's top regulator of cancer drugs interceded in a review of a Replimune skin cancer therapy, contributing to its ...