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Syndax Pharmaceuticals, Inc.

https://www.syndax.com/

Latest From Syndax Pharmaceuticals, Inc.

US And EU Approvals In First Half 2021 Underscore US-First Orientation Of Novel Drug Development

Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.

Approvals Review Pathway

Strides Fights COVID-19-Led Sales Slump With Endo Assets, Sputnik V

After a COVID-19-led manufacturing halt at its India facility and a slowdown in US launches hit Strides during the first quarter of FY22, the Indian firm is trying to fight back with an acquisition of assets from Endo and a growth strategy for Stelis Biopharma’s vaccines business, led by Sputnik V.

Sales & Earnings India

Revamped Manufacturing Process Yields Fast-Track Ryplazim Approval Three Years Later

Plasminogen therapy for unmet need licensed after Prometic took the time to develop a manufacturing process it could validate.

Manufacturing Quality

Keeping Track: StrataGraft Continues US FDA’s Biologic Center Approvals Streak; Another CRL For Avenue’s Tramadol IV

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

US FDA Performance Tracker Complete Response Letters
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    • Large Molecule
      • Antibodies
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