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Keeping Track: Approvals For Addyi, Adcetris; Merck Bulks Up Keytruda Filings

Executive Summary

The latest drug development news and highlights from our FDA Performance Tracker.

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Novel COPD Exercise Claims Eluded Boehringer In Bid to Differentiate Striverdi

Sponsor’s claimed impact on exercise tolerance was not adequately supported and should not serve as a marketing advantage for the chronic obstructive pulmonary disease drug, FDA review staff said. However, Boehringer Ingelheim’s failed attempt for the exercise-related labeling language spurred the agency to clarify the types of studies and endpoints that potentially could support such claims.

Keeping Track: US FDA Clears Santen’s Omlonti, Fennec’s Pedmark; Lilly’s Retevmo Adds Tumor-Agnostic Claim

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

October Outlook For US FDA Approvals: Goal Dates Are Sparse, But Backlog Looms

Upcoming user fee goal dates include AstraZeneca’s tremelimumab, Amicus’ AT-GAA, and drug delivery technology-driven NDAs from Supernus/US Worldmeds and scPharmaceuticals

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