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FDA News

2/8/12 - FDA grants Roche's pertuzumab Priority Review for previously untreated HER2-positive metastatic breast cancer

Basel,-- Roche today announced that the U.S. Food and Drug Administration has accepted the company's Biologics License Application for pertuzumab and granted Priority Review. The FDA confirmed the action date is June 8, 2012. "We are pleased that the FDA has granted pertuzumab a Priority Review because new medicines are needed for HER2-positive br

2/8/12 - FDA Insists on Priority Review For VMA Drug Ocraplasmin

Even though ThromboGenics NV decided not to seek a priority review of its BLA for its symptomatic vitreomacular adhesion drug ocraplasmin, the FDA decided to bestow one on the company anyway. Because of resource constraints, the company explicitly opted for a standard review when it filed with the FDA late last year. The FDA's move is not likely to

2/8/12 - Genzyme Announces FDA Approval of Framingham Manufacturing Plant

Genzyme, a Sanofi company, announced that the Food and Drug Administration has approved its manufacturing plant in Framingham, Mass., for the production of Fabrazyme Â®.

2/8/12 - Medtronic Announces 510k Clearance for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer for Spine Surgery

Medtronic, Inc. announced that it has received 510 clearance from the Food and Drug Administration for the Aquamantys Â® SBS 5.0 Sheathed Bipolar Sealer, a new addition to the spine portfolio of the company's Advanced Energy business.

2/8/12 - The Apothecary Shops Reaches Agreement with Pfizer to Distribute Inlytaâ?¢

"The Apothecary Shops is excited to be included in the limited network of pharmacies managing Inlytaâ?¢," said Keith Cook, RPh., President of The Apothecary Shops. " Since opening its first location in Arizona in 1996, The Apothecary Shops has focused on specific areas of disease states, including oncology, and has extensive experience in providing

2/7/12 - FDA Grants Genentech's Pertuzumab Priority Review for Previously Untreated HER2-Positive Metastatic Breast Cancer

Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration has accepted the company's Biologics License Application for pertuzumab and granted Priority Review. The FDA confirmed the action date is June 8, 2012. "We are pleased that the FDA has granted pertuzumab a Priority Review because new medicines are ne

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