Keeping Track: Psoriasis Gets New Topical In Arcutis’ Zoryve; Cidara Submits IV Antifungal
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Investigational products from Minoryx and a host of other companies targeting a range of diseases are now under review by the European Medicines Agency for potential EU approval.
The Swiss drug maker will initiate a "mass dismissal" and return rights to its lead drug candidate after the US FDA alerted the company to NDA deficiencies.
Company seeks accelerated approval based on changes in neurofilament as a surrogate for efficacy; with controversy over FDA’s Aduhelm approval in Alzheimer’s still raging, agency is again faced with deciding whether biomarker data in a neurodegenerative disease with high unmet need are sufficient to justify approval in the face of a failed clinical endpoint study.