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Allergan, Inc. Receives FDA Approval for LUMIGAN(R) 0.01% as First-Line Therapy Indicated for the Reduction of Elevated Intraocular Pressure in Glaucoma Patients
IRVINE, Calif., Aug 31, 2010 -- Allergan, Inc. (NYSE:AGN) today announced the United States Food and Drug Administration (FDA) has approved LUMIGAN(R) (bimatoprost ophthalmic solution) 0.01% as a first-line therapy...

GSK and Valeant Announce New U.S. FDA PDUFA Goal Date for Ezogabine
LONDON, RESEARCH TRIANGLE PARK, N.C. and ALISO VIEJO, Calif., Aug 30, 2010--GlaxoSmithKline (NYSE: GSK) and Valeant Pharmaceuticals International (NYSE: VRX) announced today the U.S. Food and Drug Administration...

EISAI ANNOUNCES EXTENSION OF FDA REVIEW OF DRUG APPLICATION FOR INVESTIGATIONAL AGENT ERIBULIN MESYLATE
August 30, 2010 - Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO: Haruo Naito, "Eisai") announced today that its U.S. subsidiary Eisai Inc. has received notification from the U.S. Food and Drug...

Roche provides update on FDA application for T-DM1
Basel, 27 August 2010--Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) issued a Refuse to File letter for accelerated approval for the company's trastuzumab-DM1...

Genentech Provides Update on FDA Application for T-DM1
South San Francisco, Calif. -- August 25, 2010 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) issued a Refuse to File letter for...

YM BioSciences granted Orphan Drug Designation for CYT387
MISSISSAUGA, ON, Aug 10, 2010--JAK1/2 inhibitor currently in Phase II clinical study in myelofibrosis- YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM), announced that the Office of Orphan Products Development of the U.S....

YM BioSciences announces conclusion of Phase I dose-escalation and expansion of ongoing CYT387 Phase I/II clinical study
MISSISSAUGA, ON, Aug 05, 2010--YM BioSciences Inc. (NYSE Amex:YMI, TSX:YM), announced the conclusion of dose-escalation in the Phase I portion of its Phase I/II clinical trial of CYT387 at Mayo Clinic in patients...

Affymax and Takeda Announce Preliminary U.S. Registration Strategy for Investigational Drug, Hematide(TM)/Peginesatide, to Treat Anemia in Chronic Renal Failure
PALO ALTO, Calif. & OSAKA, Aug 05, 2010 -- Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Company Limited (TSE:4502), today announced that the companies have decided on a preliminary strategic path forward for...

The Gamida Cell-TEVA Joint Venture Receives FDA Fast Track Designation for StemEx
Jerusalem, Israel, June 21, 2010 --- Gamida Cell announced today that the Gamida Cell-Teva Joint Venture has received an FDA Fast Track Designation for StemEx, in development as an alternative to a bone marrow...