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Latest From PharmaEssentia Corporation
US FDA Novel Approvals Grew To 60 In 2021; CDER Cleared 50 New Agents, Turned Down 18
Approval total is one of FDA’s highest, but the large number of complete response letters obscures the staggering total of almost 80 new molecular entities and novel biologics that the agency acted on over the year.
Keeping Track: A Lawsuit-Driven Complete Response Letter, A Refuse To File Letter, And Some Good News
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
Keeping Track: US FDA Approves J&J’s Novel MS Drug Ponvory, Breakthrough Pericarditis Claim For Kiniksa’s Arcalyst
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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