US FDA told the company to add a warning to the label in late January, about a month before the generic refill cartridge was approved.

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

Both Atlas and Foresite Capital announced new funds focused on start-ups. Also, Flagship launched Vesalius with $75m in initial funding, Innoviva sold $225m in notes, Hookipa priced a $75m follow-on offering and job cuts were revealed by Epizyme, Flexion, Deciphera and Gemini. 

Drugs for COVID-19, Alzheimer’s disease and heavy menstrual bleeding due to uterine fibroids are among the latest products that are this week being considered for marketing approval by the European Medicine Agency’s human drugs evaluation committee, the CHMP.