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The FDA approved Xiaflex for the treatment of Peyronie’s disease in December 2013. Following this, Xiapex gained EU approval for the treatment of Peyronie’s disease in February 2015, making it the first and only biologic therapy indicated for the treatment of Peyronie's disease. [10]
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The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form. [11]
In February 2010 the US Food and Drug Administration (FDA) approved injectable collagenase extracted from Clostridium histolyticum for the treatment of Dupuytren's contracture in adults with a palpable Dupuytren's cord.
The U.S. Food and Drug Administration (FDA) approved the drug for use in acute pain, but Vertex aims to eventually win approval in chronic pain, too. Clinical trials are ongoing, ...
Impax Pharmaceuticals Announces Extension of Rytary TM FDA Review Date to January 21, 2013 HAYWARD, Calif.--(BUSINESS WIRE)-- Impax Pharmaceuticals,the branded products division of Impax ...
In combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test [2] Osimertinib
The drug, suzetrigine, received the FDA's official stamp of approval Thursday to be sold as a 50-milligram prescription pill taken every 12 hours, according to a press release.