Keeping Track: J&J Amivantamab, Infectious Disease Agents From Iterum, VBI And Atox Submitted; Another Furoscix CRL
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Keeping Track: TGT’s Ukoniq Is Latest PI3K Inhibitor To Fall; GSK’s Daprodustat, Aeglea’s Pegzilarginase Headline Submissions
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
November Could See US FDA Action On Five Breakthrough Applications, Nine Novel Agents
BioMarin’s Voxzogo, J&J’s cilta-cel and Takeda’s maribavir are among the novel agents with goal dates on US FDA’s November user fee calendar.
ScPharmaceuticals Hopes To Win Payer Favor As It Prepares For Furoscix Resubmission
The company announced interim results of the FREEDOM-HF study showing nearly $18,000 in savings per heart failure patient.