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More Drug Approval Transparency Needed: Studies

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Oregon State University says two research studies show that more drug approval transparency is needed.

Panel to Mull 2024 Flu Vaccine Strain

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Federal Register notice: FDA announces a 10/5 Vaccines and Related Biological Products Advisory Committee meeting to discuss the 2...

FDA Gives Fast Track to Rett Gene Therapy

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FDA grants Taysha Gene Therapies a fast track designation for TSHA-102, an intrathecally delivered AAV9 gene transfer therapy for ...

FDA Approves 1st Tysabri Biosimilar

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FDA approves a Sandoz BLA for Tyruko (natalizumab-sztn), the first biosimilar to Biogens Tysabri (natalizumab) injection for treat...

Objectionable Conditions in Clinical Investigation

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FDA warns Angela Stupi in Cranberry Twp., PA, about violations in her conduct of two trials with investigational drugs.

FDA Panel to Review Diabetes NDA Dispute

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FDA says its Endocrinologic and Metabolic Drugs Advisory Committee will meet 9/21 to review and vote on an Intarcia Therapeutics N...

Regulate Cannabis Under Existing Law: CFCR

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The Council for Federal Cannabis Regulation says FDA should use its enforcement discretion to regulate cannabis products now while...

FDA Warning on Dr. Bernes Eye Drops

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FDA issues a warning against using Dr. Bernes MSM Drops 5% Solution and LightEyez MSM Eye Drops Eye Repair due to bacterial or fu...

Comments Extended on Cell, Gene Therapies

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Federal Register notice: FDA extends the comment period for a 7/14 notice that announced the availability of a draft guidance enti...

Workshop on Clinical Study Diversity

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Federal Register notice: FDA announces an 11/29-30 public workshop entitled Workshop to Enhance Clinical Study Diversity.