Tag: response letter

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...
December 5, 2017

IntelGenx To Regain Rights for RIZAPORT After RedHill Ends Partnership

IntelGenx announced it received notice that RedHill Biopharma intends to end their agreement for the co-development and commercialization of RIZAPORT.
November 1, 2017

IntelGenx and RedHill Biopharma Resubmit RIZAPORT NDA

IntelGenx announced in partnership with RedHill Biopharma announced they resubmitted the 505(b)(2) NDA to the FDA for RIZAPORT 10 mg.
April 21, 2017

Vernalis Receives NDA Response from FDA

Vernalis plc announced it received a complete response letter (CRL) from the US Food and Drug Administration's regarding CCP-07.