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Ozempic OK’d for Reducing Major Cardio Events
[176 Words]
[ Price : $8.95]
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| FDA approves a new indication for Novo Nordisk’s Ozempic (semaglutide) injection 0.5 mg or 1 mg — reducing the risk of major adverse cardiovascular events in adults with Type 2 diabetes and known heart disease. |
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01/17/2020
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Can a Name Misbrand a Drug? FDA Study
[131 Words]
[ Price : $8.95]
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| FDA seeks comments on new proposed research by CDER’s Office of Prescription Drug Promotion on promotional implications of proprietary drug names. |
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01/17/2020
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FDA Panel Split on Durect Pain Drug
[209 Words]
[ Price : $8.95]
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| FDA’s Anesthetic and Analgesic Drug Products Advisory Committee issues a split vote (6 to 6) on the approval of Durect Corp.’s surgical pain drug Posimir (bupivacaine extended-release solution). |
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01/17/2020
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CDRH Radiation Safety Panel Seeks Members
[67 Words]
[ Price : $8.95]
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| Federal Register notice: FDA requests nominations for members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee. |
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01/17/2020
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Move Away from Traditional Duodenoscopes: FDA
[194 Words]
[ Price : $8.95]
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| A new FDA safety communication recommends that hospitals and endoscopy facilities transition away from fixed endcap duodenoscopes to those with newer design features that eliminate the need or make it easier to reprocess. |
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01/17/2020
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Medtronic Safety Notice on Imaging System
[97 Words]
[ Price : $8.95]
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| Medtronic issues an urgent field safety notice about the potential for navigational inaccuracy when its O-arm O2 Imaging System’s auto-registration feature is used in conjunction with an image-guided surgery system. |
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01/17/2020
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Fusion IV Recalls Sterile Drug Products
[76 Words]
[ Price : $8.95]
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| Fusion IV Pharmaceuticals (dba Axia Pharmaceutical) recalls all unused sterile drug products within expiry due to a lack of sterility assurance. |
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01/17/2020
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House Members Seek FDA Info on Complex Generics
[356 Words]
[ Price : $8.95]
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| Bipartisan House Energy and Commerce Committee ask FDA to provide information on the agency’s approval performance on complex generic drugs, saying they are “lagging” behind other drugs in reaching the market. |
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01/17/2020
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TG Therapeutics Rolling NDA for Lymphoma Drug
[196 Words]
[ Price : $8.95]
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| TG Therapeutics begins a rolling NDA submission for umbralisib, a dual inhibitor of PI3K-delta and CK1-epsilon for treating patients with previously treated marginal zone lymphoma and follicular lymphoma. |
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01/16/2020
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