Search Results for Cystic Fibrosis

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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

Cystic Fibrosis: EMA Considers Revisions to Guidance for Developing New Drugs By Zachary Brennan - Published 01 August 2016

As the knowledge of the genetic principles and other recent developments in the field of cystic fibrosis (CF) has provided more insight into the pathophysiology of the disease, the European Medicines Agency (EMA) on Monday announced its intention to update certain outdated elements in its guidance.

Categories: News, Europe, EMA, Drugs, Due Diligence, Government affairs, Research and development

Tags: EMA guidance, CF, cystic fibrosis, CFTR

New CF Therapy Approved, Once Again Based on Help From Patient Group By Alexander Gaffney, RF News Editor - Published 25 March 2013

Categories: US, FDA, CDER

Tags: Cystic Fibrosis, CF, approval

NICE Greenlights New Cystic Fibrosis Drug in UK By Louise Zornoza, RegLink - Published 29 November 2012

Categories: NICE, Reimbursement

Tags: Cystic Fibrosis, CF, UK

Novartis Cystic Fibrosis Drug Cleared for NHS Use By Louise Zornoza, RegLink - Published 25 October 2012

Categories: NICE

Tags: Cystic Fibrosis, Forest, Novartis, Latest News, UK, NHS, guidance

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