Tag: Complete Response Letter
January 18, 2019
Immunomedics Receives Complete Response Letter From FDA for Sacituzumab Govitecan Biologics License Application
Immunomedics (NASDAQ:IMMU) a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced it has received a Complete Response Letter... December 20, 2018
ADMA Biologics Provides Regulatory Update on BIVIGAM PAS Submissions
ADMA Biologics (NASDAQ:ADMA) a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures, markets and develops specialty plasma-derived biologics... June 13, 2018
scPharmaceuticals Receives Complete Response Letter from the FDA for FUROSCIX
scPharmaceuticals (Nasdaq:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of... May 8, 2018
Agile Therapeutics Reports First Quarter 2018 Financial Results
Agile Therapeutics (Nasdaq:AGRX), a women’s healthcare company, today reported financial results for the three months ended March 31, 2018 and... March 27, 2018
Antares Pharma Provides XYOSTED Regulatory Update
Antares Pharma (NASDAQ:ATRS) today announced that the official minutes from the Type A meeting with the U.S. Food and Drug Administration... February 16, 2018
Apricus Biosciences Receives Complete Response Letter from FDA for Vitaros
Apricus Biosciences (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines in urology and rheumatology, today announced that the U.S. Food and... January 24, 2018