Keeping Track: US FDA Approvals Of Saphnelo, Nexviazyme Balanced By CRLs For Rolontis, Treosulfan, Tenapanor
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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Sanofi wants the European Medicines Agency to re-examine its opinion that the company’s drug for Pompe disease does not qualify as a new active substance.
GentiBio closed a $157m series A venture capital round, while clinical trial innovator Reify Health raised a $220m series C and Neurelis secured $150m. Also, IPOs slowed in August, but Adagio and Eliem grossed $309.4m and $80m, respectively, and RNA firm Greenlight will go public in a $282m SPAC deal.
Fears that US regulators would take issue with AstraZeneca's decision to change the endpoints of a second pivotal trial for anifrolumab were unfounded and the first-in-class type I interferon inhibitor is the first new treatment for systemic lupus erythematosus in more than 10 years.