ADMA Biologics Receives PDUFA Date for RI-002
ADMA Biologics Inc (ADMA)
Last adma biologics inc earnings: 3/12 04:05 pm
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Source: GlobeNewswire
Resubmission of Biologics License Application (“BLA”) Reinforces the Company’s Commitment to Commercialize Novel Therapies for Immune Compromised Patients to Address Unmet Medical Needs RAMSEY, N.J. and BOCA RATON, Fla., Oct. 17, 2018 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical company that develops, manufactures and markets specialty plasma-based biologics for the treatment of Primary Immune Deficiency Disease (“PIDD”) and the prevention and treatment of certain infectious diseases, announces that the U.S. Food and Drug Administration (“FDA”) has acknowledged the receipt of ADMA’s September 28, 2018 BLA resubmission for RI-002. The FDA stated that it considers the RI-002 BLA resubmission ‘a complete, Class 2 response’ and has established an action due date of April 2, 2019, under the Prescription Drug User Fee Act (“PDUFA”). “We are excited to receive the action date for RI-002 and look
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ADMA
Earnings
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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