ADMA Biologics Submits Response and Provides Supplemental Information to FDA for BIVIGAM® Complete Response Letter
ADMA Biologics Inc (ADMA)
Last adma biologics inc earnings: 3/12 04:05 pm
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ir.admabiologics.com
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Source: GlobeNewswire
RAMSEY, N.J. and BOCA RATON, Fla., Jan. 07, 2019 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures, markets and develops specialty plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases, announces that the Company has submitted responses to the U.S. Food and Drug Administration (“FDA”) Complete Response Letter (“CRL”) received on December 19, 2018 for BIVIGAM®’s (Intravenous Immune Globulin [Human], 10%) (“IVIG”) Prior Approval Supplement (“PAS”). The Company anticipates receiving an acknowledgement letter from the FDA within 30 days, and plans to provide appropriate updates on the progress of the BIVIGAM® PAS review. About ADMA Biologics, Inc. (ADMA) ADMA Biologics is a vertically integrated commercial biopharmaceutical company that manufactures, markets and develops specialty plas
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ADMA
Earnings
- 2/28/24 - Miss
ADMA
Sec Filings
- 4/15/24 - Form ARS
- 4/15/24 - Form DEFA14A
- 4/15/24 - Form DEF
- ADMA's page on the SEC website