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.
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Following regulatory setbacks in the US and also now in the EU, DBV Technologies is to conduct a new pivotal trial of a modified version of its peanut allergy patch to support its efforts to win marketing approval.
Keeping Track: US FDA Is Approving JAK Inhibitors Again, Starting With Incyte’s Opzelura; Seagen’s Tivdak Cleared
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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