Replimune said the agency had issued a complete response letter regarding the company’s biologics license application for RP1 ...

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

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 ...

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.

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

The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...

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

The Biologics License Application for full licensure of the Moderna COVID-19 vaccine, mRNA-1273, for active immunization to prevent COVID-19 in individuals 18 years of age and older has been ...

RED BANK, N.J., April 8, 2021 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced ...