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Guide on Scientific Info on Unapproved Uses

[ Price : $8.95]

FDA posts a revised draft guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on...

Generic Animal Drug User Fee Rates

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FDA sets the rates and payment procedures for fiscal year 2024 generic new animal drug program user fees.

FDA Sets Animal Drug User Fee Rates

[ Price : $8.95]

Federal Register notice: FDA announces the rates and payment procedures for fiscal year 2024 animal drug user fees.

FDA Approves Zymfentra as Maintenance Therapy

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FDA approves a Celltrion BLA for Zymfentra (infliximab-dyyb) for maintenance therapy in adults with moderately to severely active ...

Panacea Biotec Gets 9-item FDA-483

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FDA issues Panacea Biotec Pharma a nine-item Form FDA-483 after inspecting the firms Himachal Pradesh, India manufacturing 10/3-12...

ImmunityBio Refiles Bladder Cancer BLA

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ImmunityBio refiles its BLA for Anktiva (N-803) in combination with Bacillus Calmette-Gurin (BCG) for treating patients with BCG-u...

Complete Response on Dupixent sBLA

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FDA sends Sanofi and Regeneron a complete response letter on their supplemental BLA for Dupixent (dupilumab) and its use in chroni...

Medtronic Warning on McGrath Video Laryngoscopes

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FDA posts a Medtronic notice warning healthcare professionals about stolen defective McGrath MAC video laryngoscopes that have bee...

Keytruda Positive Data in Cervical Cancer

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Merck says its Keytruda (pembrolizumab) plus concurrent chemoradiotherapy reduced the risk of disease progression or death by 30% ...

Guide on Drug Benefit-Risk Assessments

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Federal Register notice: FDA makes available a final guidance entitled Benefit-Risk Assessment for Human Drug and Biological Produ...