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Javelin NDA for Injectable Diclofenac Sodium

[ Price : $8.95]

Javelin Pharmaceuticals submits an NDA for Dyloject (diclofenac sodium) Injection, indicated for managing acute moderate-to-severe...

FDA Fast Track for Multiple Myeloma Drug

[ Price : $8.95]

FDA grants fast track status to Keryx Biopharmaceuticals for KRX-0401 (perifosine), an oral anti-cancer agent that inhibits the ph...

FDA OKs Dyax NDA With REMS

[ Price : $8.95]

FDA approves a Dyax NDA for Kalbitor (ecallantide), indicated for treating hereditary angioedema (HAE) acute attacks.

TMJ Implants Seeks En Banc Review of Appellate Loss

[ Price : $8.95]

Embattled device maker TMJ Implants petitions the 10th Circuit Court of Appeals to grant an en banc review of an October decision ...

Objectionable Conditions Seen at Centra IRB

[ Price : $8.95]

CDRH warns Centra Health IRB about violations of regulations intended to ensure that accurate data are submitted with medical devi...

Drug Fact Boxes Questioned, Defended

[ Price : $8.95]

An Australian physician raises questions about the worth of U.S. research showing that including drug fact boxes in DTC ads helps ...

FDA Clears OIS Portable EyeScan

[ Price : $8.95]

FDA clears an Ophthalmic Imaging Systems 510(k) for the OIS EyeScan, a new portable imaging device that provides imaging of the ey...

Petition Asks Articaine Product Terminal Sterilization

[ Price : $8.95]

A citizen petition asks FDA not to approve any articaine-containing dental anesthetics manufactured with aseptic processing rather...

Investors Should Have Found Vioxx Problems: Merck

[ Price : $8.95]

Attorneys for Merck say that investors shouldnt be allowed to sue the company for fraud over Vioxx because they didnt work hard en...

FDA Publishing Adapalene Bioequivalence Guidances

[ Price : $8.95]

FDA says it is publishing four guidances for individual adapalene products recommending comparative clinical trials for any ANDAs.