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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), an ...
Tricida Inc., as expected, said the FDA declined to approve its NDA for veverimer as a treatment for chronic metabolic acidosis due to deficiencies in the NDA. With an Aug. 22 PDUFA date set and ...
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 FDA ...
Alkermes Plc. ALKS announced that it has received a Complete Response Letter (CRL) from the FDA regarding its new drug application (NDA) for ALKS 3831 (olanzapine ...
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