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Latest From Amgen, Inc.
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
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.
Libtayo is the first immunotherapy to demonstrate an improvement in OS, PFS and ORR in advanced cervical cancer and approval in this indication could kickstart its lackluster sales to date.
ANDA action rate dipped below the 90% mandate in second fiscal quarter, another illustration of the effect the pandemic and other issues have on US FDA’s generic drug assessment system.
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