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Insulet Recalls 400K OmniPods

[ Price : $8.95]

Insulet Corp. recalls 400,000 units of its OmniPod (Pod) Insulin Management System, citing the possibility that some devices may h...

uniQure Setback on Glybera Gene Therapy

[ Price : $8.95]

FDA tells uniQure that it will need to conduct more than one additional study to support a BLA submission for Glybera (alipogene t...

Joint Pain Class Warning on DPP-5 Diabete Drugs

[ Price : $8.95]

FDA requires a warning on all diabetes-treating dipeptidyl peptidase-4 (DPP-4) inhibitors because they may cause joint pain that c...

Telesta BLA Accepted for Bladder Cancer Therapy

[ Price : $8.95]

FDA accepts for review a Telesta Therapeutics BLA for MCNA for treating bladder cancer.

Guidance on Naming Biological Products

[ Price : $8.95]

Federal Register Notice: FDA releases a draft guidance: Nonproprietary Naming of Biological Products.

Guidance on No-Tobacco-Sale Order

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance: Determination of the Period Covered by a No-Tobacco-Sale Order (NTSO) and Compli...

FDA Proposes 6 Biological Product Names

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Federal Register Proposed rule: FDA proposes to designate official names and proper names for certain biological products includin...

FDA Approves Sunovion sNDA for Aptiom

[ Price : $8.95]

FDA approves a Sunovion Pharmaceuticals supplemental NDA for Aptiom (eslicarbazepine acetate) as monotherapy for treating partial-...

FDA Clears MagVenture Electronic Depression Therapy

[ Price : $8.95]

FDA clears a MagVenture 510(k) for the MagVita TMS Therapy system for treating major depressive disorder in adult patients who hav...

FDA Takes Initial Biological Naming Steps

[ Price : $8.95]

FDA announces the new nonproprietary names for six biological products and explains its thinking on the naming convention it is fo...