FDA Approvals - FDA Accepts Filing And Grants Priority Review For DX-88 For
FDA Accepts Filing And Grants Priority Review For DX-88 For Hereditary Angioedema (Medical News Today)
Dyax Corp. (NASDAQ: DYAX) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's Biologics License Application (BLA) for DX-88 (ecallantide) for the treatment of acute attacks of hereditary angioedema (HAE) and has designated the application for Priority Review.
PLC Systems Receives Full FDA Approval For Pivotal Study Of RenalGuard(TM) In The U.S. (Medical News Today)
PLC Systems Inc. (OTC Bulletin Board: PLCSF) announced that it has received full approval from the U.S. Food and Drug Administration (FDA) for its U.S. pivotal trial to study the effectiveness of the Company's RenalGuard System(TM) and associated therapy in the prevention of Contrast-Induced Nephropathy (CIN).
FDA Approves New Drug To Alleviate Moderate To Severe Pain (Medical News Today)
The U.S. Food and Drug Administration has approved Tapentadol hydrochloride, an immediate-release oral tablet for the relief of moderate to severe acute pain. Tapentadol is a centrally-acting synthetic analgesic that is available in doses of 50 mg, 75 mg, or 100 mg.