Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration ...

The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.

These updates support Ocugen in its efforts to pursue its goal of 3 biologics license applications (BLA) in the next 3 years.

Moderna stock rises on flu vaccine data and FDA approvals, while healthcare stocks remain under pressure amid political ...

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

The FDA has accepted for Priority Review the BLA for tividenofusp alfa for the treatment of Hunter syndrome, also known as MPS II.

The FDA has decided not to approve glofitamab plus gemcitabine and oxaliplatin to treat certain patients with relapsed/refractory DLBCL.

This week, the U.S. Food and Drug Administration (FDA) posted additional information on its recently announced “Commissioner's National ...

Investing.com -- Replimune Group, Inc. (NASDAQ: REPL) stock plunged 77% after the company announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) ...

Replimune (REPL) stock in focus as the FDA rejects its lead drug RP1 as part of a combination regimen for melanoma, a type of ...

Replimune faces FDA hurdles for RP1, an innovative melanoma treatment, as it seeks a path forward after receiving a complete ...

BMO Capital Markets pointed to FDA leadership, and CBER Director Vinay Prasad in particular, as potential factors in the ...