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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

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US FDA received several applications for new molecular entities last week, including a BLA for Alphaeon's Botulinum toxin that came just three years after number trails began.

Approvals Drug Review

Kalydeco Expands Indication Without Clinical Data; Keytruda Is Latest Bladder Cancer Approval

Keeping track of US FDA approvals last week included watching the creative and the familiar.

Approvals Review Pathway

Keeping Track: Immuno-Oncology Racks Up More Approvals; Bar Still Too High For Advair Generics

The latest drug development news and highlights from our US FDA Performance Tracker.

Approvals Complete Response Letters

Expedited Review Pathways: Three More Breakthroughs, Third RMAT Awarded

US FDA's popular breakthrough therapy designation given to Proteon's vonapanitase for dialysis patients, Synthetic Biologics' ribaxamase to prevent C. difficile infection, and River Vision's teprotumumab for thyroid eye disease; Vericel's cell therapy for heart failure is designated a regenerative medicine advanced therapy.

Review Pathway Regulation

Black Box 'Best Case' Hopes On Vaginal Estradiol Dashed For TherapeuticsMD

Echoing complaints of other recent complete response recipients, TherapeuticsMD charges that US FDA's request for 12-month safety data for the dyspareunia therapy TX004HR is not consistent with earlier communications with agency.

Complete Response Letters Drug Safety

Keeping Track: Neurology And Breakthroughs Stay In Spotlight As US FDA Approves Radicava, Imfinzi; TaiMed Submits Ibalizumab

The latest drug development news and highlights from our Performance Tracker.

Approvals Review Pathway
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