Search Results for Kalydeco

Showing 1 – 4

FDA Details How Kalydeco's Indication Expanded Without New Clinical Data By Michael Mezher - Published 19 May 2017

For the first time, the US Food and Drug Administration (FDA) has expanded a drug's indication without additional clinical data.

Categories: News, US, FDA, Drugs, Regulatory strategy, Submission and registration

Tags: Kalydeco, Cystic Fibrosis

FDA Offers Specific Guidance on Bioequivalence Trials for Next Generation of 38 Generic Drugs By Zachary Brennan - Published 14 April 2016

The US Food and Drug Administration (FDA) on Thursday unveiled 38 new specific recommendations on the types of bioequivalence trials generic drug companies should run in order to win approval for their abbreviated new drug applications (ANDAs).

Categories: News, US, CDER, Clinical, Generic drugs, Government affairs, Preclinical, Research and development

Tags: generic drug, Kalydeco, Entresto, Ibrance Lenvima, cancer drug generics

Data Reporting Mistake Hits Vertex Pharmaceuticals' Stock By Alexander Gaffney - Published 29 May 2012

Tags: VX 809, VX 770, Kalydeco, Vertex, Reporting, analysis, Latest News, data

EMA Recommends Vertex's Cystic Fibrosis Drug Kalydeco By Alexander Gaffney - Published 25 May 2012

Categories: EMA

Tags: Orphan Product, Cystic Fibrosis, CF, VX 770, Kalydeco, Vertex, rare disease, Latest News, CHMP