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Healio11mon

FDA approves prior supplement application for Zynrelef vial access needle

Please provide your email address to receive an email when new articles are posted on . Heron Therapeutics announced FDA approval of its prior approval supplement application for the Zynrelef vial ...
Healio2y

FDA postpones review of bimekizumab biologics license application

Please provide your email address to receive an email when new articles are posted on . The FDA review of bimekizumab’s biologics license application was expected in the second quarter of 2023. UCB ...
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Biofrontera Inc. Announces FDA Filing of Supplemental New Drug Application for Ameluz(R) to Permit Up to Three Tubes Per Use

FDA has set a target action date of October 4, 2024sNDA supported by two Phase 1 safety studies1Aims at actinic keratosis (AK) field treatment with up to 3 tubesAn estimated 13 million treatments ...