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Bridget Silverman
Senior Editor
Latest From Bridget Silverman
On The Docket: Recent Submissions For US FDA Approval
Round-up of late summer applications recently submitted to US FDA, adapted from the Pink Sheet FDA Performance Tracker's User Fee Goal Dates chart.
US FDA Oncology Applications: Real-Time Review And Breakthrough Pathway Show Durable Appeal
Recent submissions include what could be the fourth novel agent approved under the RTOR pilot.
Keeping Track: Gavreto, Sogroya Bring Annual CDER Novel Approvals To 40; New Analgesic Products Make It Past US FDA
The latest drug approval news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Coccidioidomycosis Outlook Highlights The Limits Of Regulatory Incentives
The US FDA heard a lot about the structural, medical and especially financial barriers facing coccidioidomycosis, or Valley fever, drug development soon after the agency refused to qualify the rare fungal infection for priority review voucher incentives.
US FDA Approval Activity Could Cool Down In September
With just 10 user fee goal dates coming up, September could be break from the fast pace of FDA decisions over the summer.
Keeping Track: US FDA Has Clinical Questions For Tricida, Gilead And BioMarin; Enspryng And Winlevi Approved
The latest drug approval and decision news from the Pink Sheet’s US FDA Performance Tracker.