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Contact Lens for Pediatric Myopia Slowing Approved

[ Price : $8.95]

FDA approves CooperVisions MiSight, the first contact lens indicated to slow the progression of myopia in children between the age...

Levo Therapeutics Fast Track for Prader-Willi Drug

[ Price : $8.95]

FDA grants Levo Therapeutics a fast track designation for LV-101 (intranasal carbetocin) for treating Prader-Willi syndrome.

Proposal to Withdraw 4 NDAs

[ Price : $8.95]

Federal Register notice: FDA proposes to withdraw approval of four NDAs from multiple NDA holders because they have repeatedly fai...

OTC Drugs Panel Charter Renewal

[ Price : $8.95]

Federal Register notice: FDA announces the renewal of the Nonprescription Drugs Advisory Committee for an additional two years.

Info Collection on Device Q-Submission Program

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension for Q-Submission Program for Medical Devices.

Info Collection for Radiation Product Testing

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension for Testing Communications on Medical Devices a...

Generics See Mixed Results on Obtaining Samples: GAO

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A new Government Accountability Office report finds that generic drug companies are having mixed results from FDAs efforts to help...

Panel Backs Expanded Vascepa Use

[ Price : $8.95]

FDAs Endocrinologic and Metabolic Diseases Advisory Committee unanimously votes to recommend approval for Amarins submission to ex...

FDA Clears Safer Pentax Duodenoscope

[ Price : $8.95]

FDA clears a Pentax 510(k) for the first duodenoscope with a sterile, disposable elevator component that the agency says will redu...

Novartis Gains Approval for Sickle Cell Therapy

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FDA approves a Novartis BLA for Adakveo (crizanlizumab-tmca) for reducing the frequency of vaso-occlusive crisis in sickle cell di...