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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)...

FDA approves Hemophilia drug
Wyeth Pharmaceuticals said that it has received approval from the U.S. Food and Drug Administration (FDA) for new product enhancements for BeneFIX(R) ...

FDA Tells House Committee that Scientific Expertise Exists for Review of Biogenerics
Generic Pharmaceutical Association (GPhA) President and CEO Kathleen Jaeger issues the following statement on House Committee on Oversight and Governm...

Final PDUFA Recommendations Transmitted to Congress Will Strengthen Drug Review and Drug Safety
The FDA recently submitted to Congress its final proposal for reauthorizing the Prescription Drug User Fee Act (PDUFA IV) after reviewing public comme...

Medical Ventures Receives FDA Clearance for PeriPatch Aegis
Medical Ventures has received 510(k) clearance from the U.S. Food and Drug Administration for its new PeriPatch Aegis, a product designed to reduce co...

Roche Submits Application to the FDA for use of XELOX (Xeloda) plus oxaliplatin) With or Without Avastin for the Treatment of Advanced Colorectal Cancer
Roche announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the use of Xeloda (cap...

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