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News List

Vernalis cough and cold drug knocked-back by FDA pharmafile
August 08, 2017
Vernalis has been given a second CRL for a cough and cold treatment by the FDA this year. The therapy, known as CCP-08, has fallen foul of the issues that led to CCP-07 being rejected earlier this year, in April.
Amicus to file Fabry drug after FDA changes mind pharmaphorum
July 13, 2017
Amicus Therapeutics is to file its oral Fabry disease medicine migalastat with the FDA after the regulator dropped a demand for further efficacy data.
Samsung Bioepis receives FDA approval for Renflexis across all eligible indications pharmaceutical-technology
April 26, 2017
Samsung Bioepis has received the US Food and Drug Administration (FDA) approval for its biosimilar referencing...

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