Bridget Silverman
Senior Editor
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Latest From Bridget Silverman
Keeping Track: US FDA Greenlights Two More Novel Drugs, But Smacks Down Golodirsen
Topical Cocaine Provides US FDA With First Case Of ‘Dueling’ 505(b)(2) NDAs
Lannett and Genus’s battle parses the distinction between NMEs and NCEs and the meaning of US Hatch-Waxman exclusivity.
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.