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Nasdaq4y
BioMarin Down on CRL From FDA for Hemophilia A Candidate
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 ...
Yahoo Finance3y
Provention Bio's Teplizumab Application Receives CRL For Type-1 Diabetes; Stock Drops
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 ...
The American Journal of Managed Care3y
CRL Issued for Provention Bio's T1D Drug 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 ...
Business Insider3y
Provention Bio Receives Complete Response Letter (CRL) to Biologics License Application (BLA) for Teplizumab for the Delay of Clinical Type 1 Diabetes (T1D) in At-risk Individuals
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 ...
Business Insider4y
2 biotech stocks plummet more than 25% after the FDA rejects their drug applications
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 ...