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

Intellipharmaceutics Provides Operational Update

Intellipharmaceutics International (Nasdaq:IPCI) a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled- and targeted-release...