FDA Approval

Mylan Inc. today announced that its subsidiary Matrix Laboratories Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated Ne...

Keryx Biopharmaceuticals, Inc. today announced that KRX-0401 has received Orphan Drug designation from the U.S. Food and Drug Administration for the treatment of neuro...

K-V Pharmaceutical Company (NYSE: KVa/KVb) (the "Company"), a specialty pharmaceutical company, announced today that it has been informed by Hologic, Inc. tha...

According to Millennium Research Group , the global authority on medical technology market intelligence, because of a lack of clinical data proving device safety and effi...

EraGen Biosciences Inc., Madison, Wis., was congratulated today by SeqWright, Inc., Houston, on EraGen's successful FDA 510 market clearance of its MultiCode-RTx HSV...

Protalix BioTherapeutics, Inc. (NYSE-Amex: PLX), announced today that the Company's New Drug Application for taliglucerase alfa has been accepted for review by the ...

Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application for Anastrozole Tablets, 1mg by the U.S. Food and Drug Administration. Th...

Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application for Naratriptan Tablets USP, 1mg and 2.5mg by the U.S. Food and Drug Admin...

Roche Molecular Systems, Inc. (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food & Drug Administration cleared its new LightCycler® MRSA Advanced Test f...

PEAK Surgical, Inc. today announced the launch of the PEAK PlasmaBlade® 3.0S dissection device following 510 clearance from the U.S. Food and Drug Administration . This r...