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CGMP Deviations at Wuhu Nuowei Chemistry

[ Price : $8.95]

FDA warns Chinas Wuhu Chemistry about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

Olympus Recalls Bronchoscope Guide Sheaths

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Olympus recalls its bronchoscope single-use guide sheath kits due to potential for the radiopaque tip of the sheath component to s...

AnaptysBio Reports Positive Data on Arthritis Drug

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AnaptysBio reports positive data from a Phase 2 study of rosnilimab for treating moderate-to-severe rheumatoid arthritis.

Max Mobility Recalls Wheelchair Speed Control Dial

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Max Mobility recalls its Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial for wheelchair use due to a faulty circuit board...

DoJ Probing Inspire Marketing, Reimbursement

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The Department of Justice has requested information from Inspire Medical as part of a civil probe into its marketing, promotion, a...

FDA Clarifies Compounded GLP-1 Enforcement

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FDA clarifies its enforcement discretion timeframes for compounded tirzepatide.

Genentech Gets New Evrysdi Tablet Approval

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FDA approves a Genentech NDA for a new tablet formulation of Evrysdi (risdiplam) for treating people with spinal muscular atrophy.

Regeneron BLA Resubmitted for Multiple Myeloma

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FDA accepts for review a Regeneron Pharmaceuticals BLA resubmission for linvoseltamab for treating adult patients with relapsed/re...

Change FDA AI Policies: Gottlieb

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Former FDA commissioner Scott Gottlieb says the agency should revert to clinical decision support system regulatory policies appro...

Strukmyer Medical CGMP Violations

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FDA warns Mesquite, TX-based Strukmyer Medical about CGMP violations in manufacturing finished drugs and cosmetics.