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Keeping Track: Myovant, Almirall, MacroGenics Nab Novel Approvals; Novartis’ Inclisiran Delayed

 
• By Bridget Silverman

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

Keeping Track Feature image

The agency approved a trio of novel agents over the past week, bringing the 2020 count for US FDA Center for Drug Evaluation and Research novel approvals to 51. The number of novel agents that failed to gain approval this year also grew, to 13, thanks to a complete response letter for Novartis AG’s blockbuster hopeful inclisiran for primary hyperlipidemia.

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

 
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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.

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 
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US FDA’s March Approval Candidates Take Aim At Established Markets

 
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GSK’s Penmenvy, Bavarian Nordic’s Vimkunya Clear US FDA, Will CDC Follow?

 
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The US FDA approval of new meningococcal and chikungunya vaccines arrived in time for the 26-28 February meeting of the CDC’s Advisory Committee On Immunization Practices, if political developments allow.

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Global Pharma Guidance Tracker – February 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.

EU CHMP Opinions And MAA Updates

 
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

US FDA’s March Approval Candidates Take Aim At Established Markets

 
• By Bridget Silverman

March features nearly 20 user fee goal dates, including a crowd of novel candidates for crowded areas like hemophilia, heart disease and urinary tract infections, as well as the potentially first therapies for a rare eye disease and hyperphagia of Prader-Willi syndrome.