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Keeping Track Of Submissions: Myovant’s First Relugolix NDA; Merck Resubmits Longer Keytruda Dosing; Biogen Adjusts Aducanumab Rolling Target

 
• By Bridget Silverman

The latest news and highlights about submissions for US approval, from the Pink Sheet FDA Performance Tracker.

Submissions continue to arrive at the US Food and Drug Administration despite the restrictions and challenges posed by COVID-19, led by a new molecular entity from Myovant Sciences Ltd.. Novel biologics from Biogen Inc. and Provention Bio Inc. continue to move forward with rolling submissions, although Biogen extended the timeline for its high-profile Alzheimer’s therapy aducanumab.

FDA also started reviewing new and improved dosing regimens for Merck & Co. Inc.’s Keytruda (longer interval between doses), Genentech Inc.’s Ocrevus (shorter infusion time) and Biogen’s Plegridy...

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