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Bridget Silverman

Senior Editor

Washington, D.C.
Bridget Silverman has been covering FDA for the Pink Sheet since David Kessler was commissioner.  She keeps watch on the drug review process for the FDA Performance Tracker and the Drug Review Profile series. She covered FDA and financial beats as a Pink Sheet reporter before focusing on the drug development and approval process as an editor on Pharmaceutical Approvals Monthly and the NDA Pipeline, developing products that inform our current regulatory tracking features and in-depth FDA review coverage. In her down time, Bridget reads mystery novels and keeps track of her family and three dogs. 
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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. 

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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.

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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).

Drug Approval Standards Gene Therapy

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.

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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.

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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.

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