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Keeping Track: US FDA Clears On Target’s Cytalux, VBI’s PreHevbrio; Keytruda Grows In Adjuvant Melanoma

 
• By Bridget Silverman

The latest FDA approval news and highlights from the Pink Sheet’s US FDA Performance Tracker.

Keeping Track Feature image

The US Food and Drug Administration’s drugs and biologics centers both closed out November with a novel approval – On Target Laboratories LLC’s fluorescent imaging agent Cytalux (pafolacianine) for the Center for Drug Evaluation and Research and VBI Vaccines Inc.’s trivalent hepatitis B vaccine PreHevbrio for the Center for Biologics Evaluation and Research.

The FDA also approved new cancer claims for Merck & Co., Inc.’s Keytruda in earlier-stage melanoma patients, including adolescents,...

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