News
For the latest media releases and news about Pharmaxis Ltd, please select from the following articles. Material news announcements made by Pharmaxis are first filed with the Australian Securities Exchange (ASX) and are also available on the ASX website.
FDA Advisory Committee Recommends Approval of Aridol
Pharmaxis today announced that an advisory committee of the U.S. Food and Drug Administration (FDA) has voted to recommend the approval of Aridol™ (mannitol bronchial challenge test) for use as a bronchial test to assess bronchial hyperresponsiveness to aid in diagnosing patients who have symptoms of asthma or symptoms that are suggestive of asthma.
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Pharmaxis Applies to Market Bronchitol for Cystic Fibrosis in Europe
Pharmaxis has filed an application with the European Medicines Agency (EMeA) to market Bronchitol in Europe for the treatment of cystic fibrosis.
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Pharmaxis Commences Pivotal Bronchiectasis Study and Aligns Global Registration Strategy
Pharmaxis today announced that it has commenced screening patients in its pivotal twelve month Phase 3 trial of Bronchitol for bronchiectasis and has moved to streamline its global regulatory strategy for this indication. As part of this strategy, Pharmaxis has voluntarily withdrawn its marketing application to the Therapeutic Goods Administration (TGA) in Australia for the use of Bronchitol to treat bronchiectasis.
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