Bridget Silverman
Senior Editor
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Latest From Bridget Silverman
Keeping Track: A Quintet Of Novel Approvals
The latest drug development news and highlights from our US FDA Performance Tracker.
Keeping Track: Amarin And Nektar Signal Delays, DBV Returns, And Provention Notches A BTD
The latest drug development news and highlights from our US FDA Performance Tracker.
Fresh Or Frozen? Orchard Aims For Cryopreserved Gene Therapy Approvals Using Pivotal Trials With Fresh Cell Formulations
Orchard aims to submit three ex vivo autologous gene therapies for approval by the end of 2021, helped by a new regenerative medicine advanced therapy designation (for a rare primary immunodeficiency syndrome) and a breakthrough therapy designation (for another rare primary immunodeficiency).
Keeping Track: Turalio, Nubeqa And Accrufer Mark Trio Of Novel Drug Approvals
The latest drug development news and highlights from our US FDA Performance Tracker.
Vertex' Dueling Phase III Programs Pay Off In NDA Submission Speed
Next-generation CFTR corrector elexacaftor aims to be first cystic fibrosis product with minimal function mutations claim after winning out over VX-659 thanks to tolerability advantage in dueling Phase III programs testing combination with the components of Vertex’ Symdeko.
Pfizer Is King Of The US Biosimilar Hill
Four biosimilar candidates are under US FDA review, including what could be Pfizer’s eighth biologic approved under FDA’s 351(k) biologics license application pathway.