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Cellebration Refusing to Provide Records to FDA

[ Price : $8.95]

FDA warns San Juan, Puerto Rico-based Cellebration LLC that it is violating the Federal Food, Drug, and Cosmetic Act and agency re...

Acadias Phase 3 Trial of Intranasal Carbetocin Fails

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Acadia Pharmaceuticals says it will cease developing intranasal carbetocin after its Phase 3 COMPASS PWS trial of the drug for tre...

Regenerative Therapies Expedited Programs

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FDA publishes a draft guidance with recommendations for expedited development and review of regenerative medicine therapies for se...

CGT Trial Innovative Designs Guidance

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FDA publishes a draft guidance on agency requirements and considerations for using various clinical trial designs and endpoints to...

Interchangeable Biosimilar Bill Introduced

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Reps. Pfluger and Landsman introduce bipartisan legislation to deem biosimilars to be interchangeable upon FDA approval.

uniQure Reports Favorable Data in Huntingtons Trial

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uniQure reports favorable data on its investigational gene therapy AMT-130 in Huntingtons disease patients.

CGMP Violations at Janssen Vaccines S. Korea Plant

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FDA warns Janssen Vaccines about CGMP violations in its Incheon, South Korea, drug manufacturing facility.

CGMP Deviations in Chengdu Records Review

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FDA warns Sichuan, China-based Chengdu Brilliant Biopharmaceutical Co. about CGMP deviations in its manufacturing of active pharma...

FDA Issues Complete Response Letter for Apitegromab

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FDA issues Scholar Rock a complete response letter for its BLA seeking approval of apitegromab, indicated for treating spinal musc...

Computer Software Assurance Guidance

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FDA publishes a guidance with recommendations for computer software assurance in computers and automated data processing systems i...