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FDA Approves Next-Gen Lap-Band

[ Price : $8.95]

FDA approves a ReShape Lifesciences PMA supplement for the companys next-generation Lap-Band 2.0 FLEX, an implant indicated for we...

Phathom Pharma Files NDA for Heartburn

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FDA accepts for review a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) as a daily treatment for heartburn associated with ...

Guide on DTC Quantitative Efficacy/Risk Info

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FDA issues a revised final guidance entitled Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Pro...

Device CEO Pleads Guilty in Covid Test Scheme

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Former Decision Diagnostics CEO Keith Berman (Westlake Village, CA) pleads guilty to securities fraud, wire fraud, and obstruction...

FDA Requiring Less Burdensome Isotretinoin REMS

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FDA tells isotretinoin manufacturers that they must modify their iPLEDGE Risk Evaluation and Mitigation Strategy to minimize the b...

NDA Resubmission on Hypoparathyroidism Accepted

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FDA accepts an Ascendis Pharma NDA resubmission for TransCon PTH (palopegteriparatide) for treating adults with hypoparathyroidism...

InvaGen Pharma Recalls Vigabatrin Lot

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Ciplas InvaGen Pharmaceuticals unit recalls one lot of vigabatrin for oral solution, USP 500mg, due to seal integrity issues.

PETA Letter Hits at FDA Lab Animal 'Cruelty'

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People for the Ethical Treatment of Animals urges FDA to move away from animal experiments in its labs and use more non-animal, hu...

Pfizer BLA for Hemophilia Accepted for Review

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FDA accepts for review a Pfizer BLA for its anti-tissue factor pathway inhibitor candidate marstacimab for treating hemophilia A o...

Trump Aligned Group Sues FDA on Ivermectin

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Trump-associated America First Legal files a lawsuit against FDA and HHS for illegally concealing government records related to th...