Keeping Track: Submissions From Sanofi, Merck, Novartis; Breakthrough Designations For GSK And Takeda
The latest news of submissions and expedited review designations from the Pink Sheet’s US FDA Performance Tracker
You may also be interested in...
As Takeda pays down debt associated with the acquisition of Shire and advances R&D programs toward global filings, the company is selling its growth plan to investors – but are they buying?
Cardiovascular and Renal Drugs Advisory Committee will consider whether exploratory analyses from the PARAGON-HF trial, which narrowly missed its primary endpoint, plus demonstrated efficacy in an adjacent indication, support a new claim for heart failure patients with preserved ejection fraction.
Regulatory review resource-intensive cell and gene therapy licensing applications are rolling toward US FDA along expedited pathways, while complete response letters and missed goal dates start to stack up under pandemic inspection constraints.