A comprehensive view of FDA Drug/Device Reviews. This page highlights a small sample of our full coverage.
For real-time access, please log in to your Tissue & Hygiene Market Intelligence Service.

Recent Articles

sample of recent headlines, press releases and get more..

FDA accepts priority review of Regeneron and Sanofi’s sBLA for Dupixent Medical dupilumab injectable to treat adults with prurigo nodularis; if approved, Dupixent would be only drug to treat prurigo nodularis in US

FDA suspends early-stage clinic trial of Vertex’s VX-880 stem-cell therapy to potentially cure type 1 diabetes for ‘insufficient information’ to approve increased dose in tests; Vertex hopes continuing studies in Canada will assuage FDA concerns

Biotech Pulse: Regeneron acquires cancer drug firm Checkmate Parmaceuticals for US$250M; Moderna reports bivent COVID-19 booster superior against Beta, Omicron variants after six months and FDA gives AstraZeneca Enhertu lung cancer drug priority review

Biotech Pulse: SELLA obtains right to develop and commercialize GenFleet Phase 1 cancer drug GFH009 globally outside China; Merck's pneumococcal vaccine Vaxneuvance review extended and Arca Biopharma's COVID drug rNAPc2 fails mid-stage Phase 2b study

AGC Biologics announces contract to manufacture materials for Phase 1 clinical trials of Allergy Therapeutics’ peanut allergy vaccine candidate; trial will commence later in 2022

Ask us about our Tissue & Hygiene market view

Trending Chart

Interactive chart with headline count