ADMA Biologics Provides Regulatory Update for BIVIGAM®
ADMA Biologics Inc (ADMA)
Last adma biologics inc earnings: 3/12 04:05 pm
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US:NASDAQ Investor Relations:
ir.admabiologics.com
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Source: GlobeNewswire
RAMSEY, N.J. and BOCA RATON, Fla., Oct. 11, 2018 (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 it has received a formal communication from the U.S. Food and Drug Administration (“FDA”) stating that the FDA considers the Company’s recent response to the agency’s information request related to the Prior Approval Supplement (“PAS”) submission a major amendment. As a result, the FDA has informed the Company that they require an additional two months to complete their review of the PAS submitted in June 2018 to amend the Biologics License Application (“BLA”) for BIVIGAM®. The FDA has established a target action date of December 18, 2018 for the PAS under the Prescription Drug User
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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