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ADMA Biologics Inc (ADMA.OQ)

ADMA.OQ on NASDAQ Stock Exchange Capital Market

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Latest Key Developments (Source: Significant Developments)

Adma Biologics Receives FDA Approval For License Transfers For Bivigam And Nabi-Hb
Monday, 8 Jul 2019 

July 8 (Reuters) - ADMA Biologics Inc ::ADMA BIOLOGICS RECEIVES FDA APPROVAL FOR LICENSE TRANSFERS FOR BIVIGAM AND NABI-HB.ADMA BIOLOGICS - FDA NOTIFIED LICENSES FOR BIVIGAM & NABI-HB REVOKED FROM BIOTEST PHARMACEUTICALS & TRANSFERRED, ISSUED TO CO'S U.S. LICENSE NO. 2019.  Full Article

ADMA Biologics Gets Patent for Treatment, Prevention of Pneumococcal Infections
Wednesday, 17 Apr 2019 

April 17 (Reuters) - ADMA Biologics Inc ::ADMA BIOLOGICS GRANTED U.S. PATENT FOR TREATMENT AND PREVENTION OF PNEUMOCOCCAL INFECTIONS.ADMA BIOLOGICS INC - TERM OF PATENT EXTENDS TO MARCH 2037..  Full Article

ADMA Biologics Receives Department Of Health And Human Services U.S. License
Wednesday, 3 Apr 2019 

April 2 (Reuters) - ADMA Biologics Inc ::ADMA RECEIVES DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S. LICENSE.ADMA BIOLOGICS INC - LICENSE AUTHORIZES ADMA TO MANUFACTURE AND ENTER INTO INTERSTATE COMMERCE WITH ASCENIV.ADMA BIOLOGICS INC - LICENSE COVERS BOCA RATON, FL MANUFACTURING FACILITY WHICH HAS DEMONSTRATED COMPLIANCE WITH FDA REQUIREMENTS.  Full Article

ADMA Biologics Submits Response And Provides Supplemental Information To FDA For Bivigam Complete Response Letter
Monday, 7 Jan 2019 

Jan 7 (Reuters) - ADMA Biologics Inc ::ADMA BIOLOGICS SUBMITS RESPONSE AND PROVIDES SUPPLEMENTAL INFORMATION TO FDA FOR BIVIGAM® COMPLETE RESPONSE LETTER.ADMA BIOLOGICS INC - ANTICIPATES RECEIVING AN ACKNOWLEDGEMENT LETTER FROM FDA WITHIN 30 DAYS.  Full Article

ADMA Biologics Says FDA declined to approve re-launch of Bivigam
Thursday, 20 Dec 2018 

Dec 19 (Reuters) - ADMA Biologics Inc ::ADMA BIOLOGICS PROVIDES REGULATORY UPDATE ON BIVIGAM® PAS SUBMISSIONS.ADMA BIOLOGICS INC - FDA ISSUES COMPLETE RESPONSE LETTER FOR PAS DRUG SUBSTANCE, APPROVES PAS FOR DRUG PRODUCT.ADMA BIOLOGICS INC - CRL DID NOT CONTAIN ANY REQUESTS FOR ADDITIONAL MANUFACTURING RUNS.ADMA BIOLOGICS INC - BELIEVES FDA COMMENTS TO DRUG SUBSTANCE PAS SUBMISSION ARE ADDRESSABLE AND RESOLVABLE.ADMA - FDA DIDN'T REQUEST ANY INFO PERTAINING TO COMPLIANCE STATUS, CLINICAL STUDY SAFETY, OTHERS ABOUT 3RD PARTY CONTRACT MANUFACTURERS AND VENDORS.ADMA BIOLOGICS INC - WILL REQUEST A MEETING WITH FDA AND PLANS TO PROMPTLY PROVIDE FDA WITH CLARIFICATION AND RESPONSES TO ISSUES RAISED IN CRL.  Full Article

Adma Biologics Q3 Loss Per Share $0.33
Friday, 9 Nov 2018 

ADMA Biologics Inc ::ADMA BIOLOGICS REPORTS THIRD QUARTER 2018 FINANCIAL RESULTS.Q3 LOSS PER SHARE $0.33.Q3 EARNINGS PER SHARE VIEW $-0.31 -- THOMSON REUTERS I/B/E/S.Q3 REVENUE $4.2 MILLION VERSUS I/B/E/S VIEW $4.7 MILLION.  Full Article

ADMA Biologics Receives PDUFA Date For Bivigam Regulatory Submission
Thursday, 26 Jul 2018 

July 26 (Reuters) - ADMA Biologics Inc ::ADMA BIOLOGICS RECEIVES PDUFA DATE FOR BIVIGAM REGULATORY SUBMISSION.ADMA BIOLOGICS INC - ONCE PAS IS APPROVED, ADMA INTENDS TO RELAUNCH BIVIGAM IN U.S.ADMA BIOLOGICS INC - TARGET ACTION DATE FOR PAS IS OCTOBER 25, 2018 UNDER PRESCRIPTION DRUG USER FEE ACT.ADMA BIOLOGICS - ANTICIPATES RELAUNCHING BIVIGAM, UTILIZING 3 PRODUCED CONFORMANCE LOTS TO GENERATE ACCRETIVE REVENUE IN ADVANCE OF/DURING Q1 2019.  Full Article

Adma Biologics Says On July 19, Biotest Pharmaceuticals Corp And Co's Unit Entered Into Amendment No. 1 To Plasma Supply Agreement, Dated June 6, 2017
Wednesday, 25 Jul 2018 

July 24 (Reuters) - ADMA Biologics Inc ::ADMA BIOLOGICS - ON JULY 19, BIOTEST PHARMACEUTICALS CORP AND CO'S UNIT ENTERED INTO AMENDMENT NO. 1 TO PLASMA SUPPLY AGREEMENT, DATED JUNE 6, 2017.ADMA BIOLOGICS - AGREEMENT PROVIDES FOR THE SALE BY BPC TO ADMA BIOMANUFACTURING OF HYPERIMMUNE PLASMA CONTAINING ANTIBODIES TO THE HEPATITIS B VIRUS.  Full Article

ADMA Biologics Says Public Offering Of 8.37 Mln Common Shares Priced At $4.78 Per Share
Friday, 8 Jun 2018 

June 8 (Reuters) - ADMA Biologics Inc ::ADMA BIOLOGICS ANNOUNCES PRICING OF PUBLIC OFFERING OF COMMON STOCK.ADMA BIOLOGICS INC <<>> SAYS PUBLIC OFFERING OF 8.37 MLN COMMON SHARES PRICED AT $4.78/SHR.  Full Article

ADMA Biologics Files For Mixed Shelf Offering Of Up To $100 Mln
Saturday, 19 May 2018 

May 18 (Reuters) - ADMA Biologics Inc ::ADMA BIOLOGICS FILES FOR MIXED SHELF OFFERING OF UP TO $100 MILLION - SEC FILING.  Full Article