Aeglea BioTherapeutics, Inc.
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Latest From Aeglea BioTherapeutics, Inc.
Keeping Track: Travere’s Filspari, Chiesi’s Lamzede, Apellis’ Syfovre Headline US FDA Approvals; CRLs For Phathom, Biocon
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
With 37 Novel Approvals in 2022, US FDA CDER’s Five-Year Hot Streak Comes To An End; Gene Therapies Carry CBER To 8 Novel Approvals
US FDA’s novel agent count fell back to average as agency kept up high rate of complete response letters and refuse to file actions; CBER’s workload shifted to regenerative medicine.
Novel Brain Penetrant For Treating X-ALD Among Raft Of New EU Filings
Investigational products from Minoryx and a host of other companies targeting a range of diseases are now under review by the European Medicines Agency for potential EU approval.
Finance Watch: Recent Upswing Turns Down, But Two Small IPOs Launch
Shuttle Pharmaceuticals and PaxMedica launch two small initial public offerings in the US as the market awaits a significant IPO. Also, Assertio closed a $70m follow-on offering, Codiak restructures and cuts jobs, and Vilya emerges with $50m in series A venture capital.
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