BioMarin Pharmaceutical Inc. BMRN announced that the FDA has issued a complete response letter (CRL) to its biologics license application (BLA) for Roctavian (valoctocogene roxaparvovec/valrox ...

The FDA has issued a Complete Response Letter (CRL) to Provention Bio Inc's (NASDAQ: PRVB) teplizumab marketing application seeking approval for the delay of clinical type 1 diabetes (T1D ...

Charles River Laboratories International, Inc. CRL has announced the integration of Akron Bio’s (Akron) Closed System Solutions (CSS) line of liquid cytokines produced under current good ...

RED BANK, N.J., July 6, 2021 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq ... has issued a Complete Response Letter (CRL) for the Company's Biologics License Application (BLA) for teplizumab ...

The FDA issued a Complete Response Letter, halting Provention Bio's type 1 diabetes prevention drug. Provention Bio has received a Complete Response Letter (CRL) from the FDA in response to its ...

The FDA issued bad news to three biotechnology firms on Tuesday and Wednesday, sparking an investor exodus that sent shares tumbling. Gilead received a complete response letter, or CRL, from the ...