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Veopoz OKd and Eylea Issues Fixed: Regeneron

[ Price : $8.95]

FDA approves a Regeneron Pharmaceuticals BLA for Veopoz (pozelimab-bbfg) for treating adult and pediatric patients one year of age...

Merck Touts Welireg in Kidney Cancer

[ Price : $8.95]

Merck says it will submit to FDA favorable data from its LITESPARK-005 Phase 3 trial evaluating Welireg (belzutifan) for treating ...

FDA Updates Warning on UV Wands

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FDA updates its list of ultraviolet wand products that may present a potential risk of injury.

GE Mobile Patient Monitor Cleared

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FDA clears a GE HealthCare 510(k) for its Portrait Mobile wireless and wearable monitoring device.

FDA Oks Ipsens Sohonos for FOP

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FDA approves Ipsens Sohonos as the first treatment for adults and some pediatric patients with fibrodysplasia ossificans progressi...

Cardiosave Balloon Pump Recall Class 1: FDA

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FDA says the Datascope/Maquet/Getinge recall of Cardiosave balloon pumps is Class 1.

BlueWind De Novo for Incontinence Device

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FDA grants BlueWind Medical a de novo marketing authorization request for the Revi System, a tibial neuromodulation therapy for tr...

Workshop on Postapproval Pregnancy Studies

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Federal Register notice: FDA announces a 9/18-19 public workshop entitled Optimizing the Use of Postapproval Pregnancy Safety Stud...

Vanda Pushes Back on Hetlioz sNDA Hearing Denial

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A sharply-worded Vanda response to FDA says commissioner Robert Califf should reject a CDER proposed order and either approve Vand...

Medical Device, Drug Recalls Drop in Q2: Sedgwick

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The Segwick Recall Index shows that both medical device and drug recalls dropped in the second quarter of 2023 from the first quar...