Keeping Track: Enhertu Brings Anti-HER2 Therapy To Lung Cancer; Novaliq Platform Supports Two Dry Eye NDAs
Executive Summary
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.
You may also be interested in...
5 Talking Points As Sun's Cequa Hits Home Turf And There's Restasis
Cequa arrives in India, almost four years post US debut with Sun deploying what has generally been perceived as the text-book launch approach of foreign firms in the country. Scrip delves into the market dynamics in a segment where AbbVie's blockbuster Restasis is well entrenched.
October Outlook For US FDA Approvals: Goal Dates Are Sparse, But Backlog Looms
Upcoming user fee goal dates include AstraZeneca’s tremelimumab, Amicus’ AT-GAA, and drug delivery technology-driven NDAs from Supernus/US Worldmeds and scPharmaceuticals
Spectrum’s Delay In Starting Confirmatory Trial Of Poziotinib Troubles US FDA
Ahead of advisory committee review, agency cites poziotinib’s marginal anti-tumor activity, high rates of toxicity, and lack of dose optimization. Company seeks accelerated approval but was given standard review.