Keeping Track: Gilead Gets CRL For Bulevirtide, CytoDyn Withdraws Leronlimab; Eye and CNS Drug Submissions
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Crucial Moment In EU For Sanofi/GSK’s COVID-19 Vaccine, Amicus’s AAT-GAA & Y-mAbs’ Omburtamab
Vidprevtyn, from Sanofi/GSK, and drugs from Amicus and Y-mAbs are nearing the end of the European Medicines Agency review cycle. They are among the products scheduled for discussion this week by the CHMP, the EMA committee that decides whether drugs should be granted pan-EU approval.
Apellis Aims New Pegcetacoplan Data At Market, Not Regulators
The company said the user fee goal date for pegcetacoplan in geographic atrophy would move from November to February as it submitted longer-term data.
Iveric's Zimura Shows Benefit In Geographic Atrophy, An Area Poised For New Options
The company plans to file the complement C5 inhibitor with the US FDA, but Apellis already has a drug pending for the indication.