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FDA approves AVONEX PEN and dose titration regimen
28 February 2012 | By
Dosing enhancements may improve treatment experience for patients receiving AVONEX® (interferon beta-1a) for MS...
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Food and Drug Administration (FDA)
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Merck provides information on FDA post-marketing requirement for Sitagliptin
28 February 2012 | By Merck
Merck received a Warning Letter from the U.S. FDA relating to JANUVIA (sitagliptin) and JANUMET (sitagliptin/metformin HCl)...
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FDA accepts Pfizer’s New Drug Application for Tafamidis Meglumine
15 February 2012 | By Pfizer
A novel, investigational treatment for Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP)...
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FDA approves ZIOPTAN™ (tafluprost ophthalmic solution)
13 February 2012 | By Merck
ZIOPTAN™ (tafluprost ophthalmic solution) 0.0015%, the first preservative-free prostaglandin analog ophthalmic solution...
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U.S. FDA grants Priority Review for Truvada® for reducing the risk of acquiring HIV infection
13 February 2012 | By Gilead Sciences Inc
The U.S. FDA has granted a six-month Priority Review for once-daily Truvada®...
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FDA requests additional data on Novartis quadrivalent meningococcal conjugate vaccine, Menveo®
13 February 2012 | By Novartis
Novartis has received a Complete Response letter from the US FDA...
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FDA grants Roche’s pertuzumab Priority Review for previously untreated HER2-positive metastatic breast cancer
8 February 2012 | By Roche
The U.S. FDA has accepted the company’s Biologics License Application for pertuzumab...
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FDA approves Novartis drug Glivec® label
1 February 2012 | By Novartis
The US Food and Drug Administration has approved an update to the Glivec® (imatinib)* label...
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FDA approves Erivedge (vismodegib) capsule
30 January 2012 | By
The first medicine for adults with advanced basal cell carcinoma...
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U.S. Food and Drug Administration approves Pfizer’s INLYTA® (axitinib)
27 January 2012 | By Pfizer
First treatment to demonstrate superior benefit in a Phase 3 study compared with another targeted agent in advanced RCC...
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New FDA approved labeling for VYTORIN® (Ezetimibe/Simvastatin)
25 January 2012 | By Merck
The FDA has approved an updated label for VYTORIN® (ezetimibe/simvastatin)...
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Genzyme announces FDA approval of Framingham manufacturing plant
24 January 2012 | By Sanofi
The FDA has approved its manufacturing plant in Framingham, Mass., for the production of Fabrazyme® (agalsidase beta)...
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AstraZeneca and Bristol-Myers Squibb receive complete response letter from US FDA for dapagliflozin
19 January 2012 | By AstraZeneca
The FDA has issued a complete response letter regarding dapagliflozin...
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Abbott’s STARLIMS LIMS technology to be installed in FDA testing laboratories
18 January 2012 | By Abbott
The U.S. FDA will begin implementing Abbott’s STARLIMS® software-based laboratory information management system...
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U.S. Food and Drug Administration approves new formulations of Viread® for use by children living with HIV
18 January 2012 | By Gilead Sciences Inc
Gilead Sciences, Inc. announced that the U.S. FDA has approved Viread®...
