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Omrix Biopharmaceuticals has announced positive results from its Phase III pivotal clinical trial of human thrombin in achieving hemostasis in general surgery procedures.
Eisai and Pfizer announced that the FDA has approved a supplemental new drug application (sNDA) for Aricept (donepezil HCl tablets) for treatment of severe Alzheimer's disease.
Amgen announced that the FDA has issued an approvable letter for Aranesp (darbepoetin alfa) de novo once-every-two-week and maintenance once-monthly dosing regimens for chronic kidney disease patients with anemia not on dialysis.
Anesiva has announced that the FDA granted orphan drug status to product candidate 4975 for the treatment of a painful condition in the foot known as interdigital neuroma in patients who fail conservative treatments, such as foot pads, non-steroidal anti-inflammatory drugs (NSAIDs) and injections of corticosteroids, that would otherwise require removing or chemically destroying the nerve that causes the pain.
Agennix announced that the FDA has granted orphan drug designation to the company's oral formulation of Talactoferrin Alfa (talactoferrin or TLF) for the treatment of renal-cell carcinoma (RCC).
MedImmune has announced results of a study that demonstrated higher influenza serum antibody responses in children receiving its next-generation, investigational intranasal influenza vaccine, CAIV-T (cold-adapted influenza vaccine, trivalent), than in children who received the traditional injectable trivalent inactivated flu vaccine (TIV).
Genta has announced initiation of a Phase I clinical trial using a new anticancer drug derived from the company's DNA/RNA medicines program. The new compound, known as G4460, uses antisense technology to target an oncogene known as c-myb that regulates key functions in cancer cells.