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FDA Push to Move More Drugs to OTC Status

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FDA commissioner Marty Makary discusses upcoming actions to encourage more prescription-to-over-the-counter drug switches.

Cogent Bio Plans NDA for Bezuclastinib

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Cogent Biosciences says FDA has agreed to accept the companys planned NDA for cancer drug bezuclastinib under the agencys Real-Tim...

IntraBio Reports Positive Phase 3 Data on Levacetylleucine

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IntraBio reports positive results from a pivotal Phase 3 clinical trial showing that levacetylleucine significantly improved neuro...

FDA Touts ImportShield Results

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FDA says its new ImportShield program improved processing speed and volume capacity while reducing staff hours in its first four m...

AdvaMed Urges FDA to Narrow Guidance on Device QMS

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Advanced Medical Technology Association urges FDA to narrow and clarify a draft guidance on quality management system information,...

Moderna/Merck Report Positive Data on Melanoma Vaccine

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Moderna and Merck report updated five-year follow-up data that show their personalized mRNA cancer vaccine candidate, intismeran a...

FDA Seeks More Data on Capricor Cell Therapy

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FDA asks Capricor Therapeutics for a full clinical study report from the companys Phase 3 HOPE-3 trial as part of its ongoing BLA ...

ICH Drug Submission Quality Information Guidance

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FDA publishes for review and comment the International Council for Harmonization M4Q(R2) guidance establishing the location and st...

4 CGMP Issues at Integrity Partners Facility

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FDA warns Integrity Partners St. Louis, MO-based Chemisphere drug manufacturing facility about CGMP issues in its production of fi...

Valneva Withdraws BLA for Chikungunya Vaccine

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Valneva says it has voluntarily withdrawn its BLA for Ixchiq, the companys chikungunya vaccine, based on FDA safety-related restri...