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Teva Recalls Combo Products for High Blood Pressure

[ Price : $8.95]

Teva Pharmaceuticals recalls all lots of amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide com...

Former Insys VP Pleads Guilty to Racketeering

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The Justice Department says the former Insys Therapeutics vice president for sales pleaded guilty to one count of racketeering con...

Astellas Xospata Approved for Acute Myeloid Leukemia

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FDA approves Astellas Pharmas Xospata (gilteritinib) tablets for treating adult patients who have relapsed or refractory acute mye...

6 Months Pediatric Exclusivity for Lyrica

[ Price : $8.95]

FDA grants six-month pediatric exclusivity to Pfizers Lyrica based on its use in pediatric epilepsy studies.

4 New ICH Groups Moving Ahead

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The International Council for Harmonization approves concept papers and business plans for three new informal working groups and a...

Mesa Biotechs Accula RSV Test Cleared

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FDA clears a Mesa Biotech 510(k) for its Accula RSV test, a respiratory syncytial test cassette for diagnosing both children and a...

Class 1 Recall for Zimmer Spinal Fusion Stimulators

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FDA classifies as Class 1 a Zimmer Biomet recall of its EBI Osteogen Implantable Bone Growth Stimulator, SpF Plus-Mini (60 μA...

FDA OKs Bayer/Loxo Targeted Cancer Drug

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FDA approves Bayer and Loxo Oncologys Vitrakvi (larotrectinib) for treating adult and pediatric cancers in patients who have a spe...

FDA Heading to Sliding Scale of Medical Device Evidence: Lurie

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Former FDA associate commissioner Peter Lurie says FDA may have to lower its medical device approval standards if it wants to be t...

FDA Cuts Minimum Measles Antibody Potency Spec

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FDA says it is lowering the minimum measles antibody potency specification for immune globulin products.