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Genta Appeals FDA Decision on Genasense(R) in CLL
Genta announced that the Company has filed a formal appeal of the recent non-approvable decision by the Food and Drug Administration (FDA) for the Com...

Inocoll Receives FDA Approval to Commence Phase 2 Clinical Development with its CollaRx BUPIVACAINE IMPLANT for the Management of Post-operative Pain
Innocoll, a privately-held specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved its Investigatio...

PuriCore Receives FDA Approval for Endoscope Disinfectant System
PuriCore announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA), allowing it to market its proprietary Sterilo...

Stereotaxis Announces FDA Approval of Partnered 8mm Ablation Catheter
tereotaxis announced hat its partnered magnetically enabled 8mm ablation catheter has received FDA approval and will soon be commercially available in...

FDA Approves Merck diabetes pill
Merck announced t that the U.S. Food and Drug Administration (FDA) approved JANUMET™, the first and only tablet combining a dipeptidyl peptidase-4 (DP...

PETA Calls on FDA Head to Resign Over Botched Pet Food Recall
PETA President Ingrid E. Newkirk fired off a letter to Andrew von Eschenbach, calling on him to step down as commissioner of the U.S. Food and Drug Ad...

CryoCath receives FDA approval to expand STOP AF trial to full cohort of patients
CryoCath Technologies in cryotherapy products to treat cardiovascular disease, announced it has received notification from the U.S. Food and Drug Admi...

Cyprotex Extends Cloe Screen Mechanism-Based Inhibition Service to Include 4 Additional Cytochrome P450 Isoforms
Cyprotex announced that it has enhanced its Cloe Screen Mechanism-Based Inhibition service to include 4 additional cytochrome P450 (CYP450) isoforms. ...

FDA Accepts Synthemed's Pre-Market Approval (PMA) Application for REPEL-CV
SyntheMed, a biomaterials company engaged in the development and commercialization of anti-adhesion and drug delivery products, today announced that t...

Mylan Announces Tentative FDA Approval for Divalproex Sodium Extended-Release Tablets
Mylan Pharmaceuticals has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA)...

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