Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

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. 

Latest From Bridget Silverman

Keeping Track: Lilly’s Mounjaro Enters Diabetes Market; Biogen/Eisai Lecanemab Leads Neuroscience News

CDER turned in its 13th novel approval of 2022 on Friday the 13th, and other drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

US FDA Performance Tracker Approvals

Biohaven’s ‘EpiPen For Migraine’ Intranasal Candidate Rounds Out Prospective Pfizer Portfolio

Real-world evidence – and maybe even an opioid-sparing claim – will be part of Pfizer’s efforts to grow the CGRP space if its $11.6bn bid for Biohaven’s migraine assets goes through. Nurtec ODT (rimegepant) is the star, but pending fast-acting zavegepant could play a valuable supporting role.

M & A Real-World Evidence

Keeping Track: AZ’s Busy Oncology Biz, Phathom’s Voquezna Approval, And A Trio Of Complete Response Letters

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

US FDA Performance Tracker Approvals

Recent US FDA Breakthrough Therapy Designations, From Mass Market Vaccines To Rare Diseases

Merck’s latest pneumococcal vaccine and Pfizer’s RSV vaccine notched new BTDs, along with Zambon’s inhaled antibiotic for non-CF bronchiectasis, Acer’s vascular Ehlers-Danlos syndrome drug and Dizal’s targeted lung cancer candidate.

US FDA Performance Tracker Review Pathway

Orphalan Cuvrior Earned Earlier Use With Head-To-Head Trial Against Frontline Wilson’s Disease Drug

French orphan specialist developed new assay for primary endpoint to show non-inferiority of its room temperature-stable salt of trientine, earning a broader FDA approval than generically available second-line trientine products.

Rare Diseases Approvals

Keeping Track: Mycovia Vivjoa, BMS Camzyos Approvals Bring FDA’s 2022 Novel Drug Tally To 12

US FDA closed out the month of April with two new molecular entity approvals that address underserved markets but carry some safety concerns.

US FDA Performance Tracker Drug Review
See All
UsernamePublicRestriction

Register