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Heron Therapeutics, Inc.

http://herontx.com/

Latest From Heron Therapeutics, Inc.

Half Of US FDA’s Breakthrough Therapy Designations Have Resulted In Approval

Popular expedited review program results in a higher approval rate than the related fast track designation, but the COVID-19 era is seeing a drop in designations and a rise in complete response letters for BTD programs.

Review Pathway Drug Review

Keeping Track: Keytruda Adds TNBC Claim; Finerenone, Brincidofovir, HTX-011 Submitted; CRL For Supernus’ ADHD Drug

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

US FDA Performance Tracker Drug Review

Coronavirus Update: BioNTech Gets €375m From Germany To Fund Vaccine

Plus: Valneva confirms supply deal with the UK government for its inactivated vaccine candidate; Humanigen expands manufacturing ahead of Phase III data.

Clinical Trials Companies

US FDA Picks Up The Pace Of Complete Response Letters Over June And July

The year began with an unusually low number of CRLs, but a recent burst of non-approval actions suggests a COVID-19 effect.

Complete Response Letters US FDA Performance Tracker
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
    • Drug Delivery
      • Controlled Release
  • Other Names / Subsidiaries
    • A.P. Pharma, Inc., Heron Therapeutics B.V.
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