Sirion Therapeutics Receives NDA Acceptance And Priority Review From The FDA For Durezol(TM) In The Treatment Of ... (Medical News Today) Sirion Therapeutics, Inc., a privately held ophthalmic-focused biopharmaceutical company, announced that its New Drug Application (NDA) for Durezol(TM) has been accepted by the U.S. Food and Drug Administration (FDA) and granted priority review. Sirion Therapeutics is seeking approval from the FDA for its investigational compound Durezol(TM) (difluprednate ophthalmic emulsion) 0.
Center For Molecular Medicine Among First To Offer New FDA Approved Test To Aid In Treatment Of Prostate Cancer (Medical News Today) The Center for Molecular Medicine (CMM) announced it is one of the first laboratories in the nation to offer a new, FDA-approved test that will aid in the treatment of metastatic prostate cancer. The CMM (http://www.cmmdx.org) is offering the CellSearch(TM) System from Veridex (http://www.veridex.
FDA Accepts For Review OVATION's Two NDA Submissions For Sabril(R) (Medical News Today) OVATION Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company's new drug applications (NDA) for Sabril (vigabatrin) in two types of epilepsies. The FDA assigned a priority NDA review for Sabril for the treatment of Infantile Spasms (IS), and will review the submission for refractory complex partial seizures (CPS) in the same time frame.