by Peter Ciszewski | Aug 15, 2017
Shire announced that the Marketing Authorization Application (MAA) for lifitegrast, submitted on August 7 has been validated. If approved, lifitegrast would be the first and only treatment in a new class of drugs (LFA-1 antagonist) to address the signs and symptoms of...
by Peter Ciszewski | Aug 10, 2017
Philippe M. Maitre, Executive Vice President, US Operations discusses Onxeo and the company’s focus on orphan oncology products. Onxeo was created through the merger of BioAlliance Pharma, a French innovative company based in Paris specializing in the...
by Peter Ciszewski | Aug 8, 2017
Kadmon Holdings announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to tesevatinib for the treatment of non-small cell lung cancer (NSCLC) with epithelial growth factor receptor (EGFR)-activating mutations. The drug was...
by Peter Ciszewski | Jul 27, 2017
More good news for the Duchenne muscular dystrophy (DMD) community as Capricor Therapeutics revealed the official minutes of the meeting held recently between the U.S. Food and Drug Administration (FDA) and Capricor to discuss the development of intravenous CAP-1002...
