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Keeping Track: Submissions From Sanofi, Merck, Novartis; Breakthrough Designations For GSK And Takeda

 
• By Bridget Silverman

The latest news of submissions and expedited review designations from the Pink Sheet’s US FDA Performance Tracker

Earnings season brings information ranging from news tidbits, like a new brand name for BioMarin Pharmaceutical Inc.’s hemophilia gene therapy, to submissions including Sanofi’s novel biologic sutimlimab and new indications for Merck & Co. Inc.’s Keytruda and Novartis AG’s Entresto.

The ranks of breakthrough therapy designations rose by two, with BTDs announced by GlaxoSmithKline PLC (Benlysta for lupus nephritis) and Takeda Pharmaceutical Co. Ltd

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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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AMR-Targeting Drug Secures EMA PRIME Designation

 
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Global Pharma Guidance Tracker - March 2025

 
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Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.