Update for September 1, 2022

The FDA accepted the NDA for fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause and set a PDUFA date for 2/22/2023.
 
Minerva submitted an NDA for roluperidone for the treatment of negative symptoms in patients with schizophrenia.
 
The FDA accepted the NDA for efanesoctocog alfa and set a PDUFA date for 2/28/2023.
 
Iovance initiated a rolling BLA for lifileucel for the treatment of metastatic melanoma.
 
Lenacapavir was approved for the treatment of multi-drug resistant HIV-1 infection in the UK.
 
The European Commission granted conditional marketing authorization (CMA) to valoctocogene roxaparvovec (Roctavian, BioMarin), a gene therapy for the treatment of severe hemophilia A.
 
The EMA accepted the MAA for elacestrant to treat ER+/HER2- advanced or metastatic breast cancer.
 
The EMA accepted the MAA for rezafungin for the treatment of invasive candidiasis.
 
The EMA accepted the Conditional Marketing Authorization (CMA) for sparsentan for the treatment of IgAN.
 
The EMA validated the MAA for quizartinib in combination with cytarabine and anthracycline induction and cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of acute myeloid leukemia (AML) that is FMS-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD) positive.