Keeping Track: US FDA Approves Sanofi’s Dengvaxia, But Heron’s HTX-011 And Nabriva’s Contepo Fall Short
Executive Summary
The latest drug development news and highlights from our US FDA Performance Tracker.
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Dengvaxia Dengue Vaccine Finally Gets Green Light From CDC’s Advisory Committee
ACIP recommends Sanofi’s vaccine for use in persons 9 to 16 years old with a laboratory confirmation of previous dengue infection who are living in endemic areas. Recommendation comes two years after FDA licensure and following development of improved pre-vaccination screening tests.
Keeping Track: US FDA Approves Heron’s Zynrelef In Post-Op Pain; Amgen/AZ Submit Tezepelumab For Severe Asthma
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Heron Overcomes Two CRLs To Win Zynrelef Approval In Post-Op Pain
The combination of bupivacaine and meloxicam will be priced at a discount to Exparel, with Heron predicting rapid uptake. Label limited to three surgery types, but analysts expect off-label use.