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Orphan Status for Novita Pancreatic Cancer Drug

[ Price : $8.95]

FDA grants Novita Pharmaceuticals an orphan drug designation for its experimental cancer drug NP-G2-044 for treating pancreatic ca...

Pediatric Menkes Disease Drug Approved

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FDA approves a Sentynl Therapeutics NDA for Zycubo (copper histidinate) injection as the first treatment for Menkes disease in ped...

FDA 2nd Complete Response on BLA for Atara Cell Therapy

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FDA issues Pierre Fabre Pharmaceuticals a second Complete Response Letter rejecting its BLA for Atara Biotherapeutics investigatio...

Mifepristones FDA Regulation Driven by Science: JAMA

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A new JAMA analysis finds that FDAs regulation of mifepristone has been driven largely by scientific evidence and internal expert ...

FDA Accepts EMD Serono NDA for Tumor Drug

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FDA accepts for review an EMD Serono NDA for pimicotinib, a potential first-in-class systemic treatment for tenosynovial giant cel...

FDA Cites Aurobindo for Drug Supply Security Lapses

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FDA cites Aurobindo Pharma USA for multiple failures to comply with federal drug supply chain security requirements, including del...

Fast Track for Alessas Prostate Cancer Therapy

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FDA grants Alessa Therapeutics a fast track designation for Enolen, an experimental localized prostate cancer therapy.

AVID Medical Recalls Organ Recovery Bags

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AVID Medical recalls (Class 1 device correction) certain organ recovery and medical convenience kits.

FDA Guide Outlines Expectations for Bayesian Trial Designs

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A new FDA guidance details how drug developers can appropriately use Bayesian statistical methods in clinical trials intended to s...

FDA Flags Deficiencies in Aquestives Anaphylm NDA

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FDA tells Aquestive Therapeutics that deficiencies have been identified in the companys NDA for Anaphylm that currently preclude l...