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ELVT SNY OTSKY MNKD OTLK VTRS Here are the key confirmed or reported upcoming PDUFA (Prescription Drug User Fee Act) target action dates for

ELVT SNY OTSKY MNKD OTLK VTRS Here are the key confirmed or reported upcoming PDUFA (Prescription Drug User Fee Act) target action dates for remainder of month: --ELVT expected around 7/23 – Drug rivoceranib + camrelizumab (NDA). Oral VEGFR tyrosine kinase inhibitor + anti-PD-1 antibody for first-line treatment of unresectable or metastatic hepatocellular carcinoma (liver cancer). --SNY expected on 7/23 – Drug Sarclisa SC (isatuximab subcutaneous; BLA). Subcutaneous formulation of Sarclisa for multiple myeloma (in combination with standard regimens; simplifies administration vs. Iv). --OTSKY expected on 7/24 – Drug Centanafadine (NDA). Novel norepinephrine/dopamine/serotonin reuptake inhibitor (NDSRI) for ADHD in children, adolescents, and adults (first-in-class non-stimulant option). --MNKD expected on 7/26 – Drug FUROSCIX ReadyFlow Autoinjector (sNDA/SCP-111). Alternative delivery (autoinjector) of furosemide (diuretic) for edema in adults with chronic heart failure or chronic kidney disease. --OTLK expected on 7/29 - ONS-5010 / LYTENAVA (bevacizumab-vikg; BLA). Biosimilar/reference bevacizumab for wet age-related macular degeneration (AMD). --VTRS expected on 7/20 - low-dose.

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ELVT SNY OTSKY MNKD OTLK VTRS Here are the key confirmed or reported upcoming PDUFA (Prescription Drug User Fee Act) target action dates for remainder of month: --ELVT expected around 7/23 – Drug rivoceranib + camrelizumab (NDA).

Oral VEGFR tyrosine kinase inhibitor + anti-PD-1 antibody for first-line treatment of unresectable or metastatic hepatocellular carcinoma (liver cancer). --SNY expected on 7/23 – Drug Sarclisa SC (isatuximab subcutaneous; BLA).

Subcutaneous formulation of Sarclisa for multiple myeloma (in combination with standard regimens; simplifies administration vs.

Iv). --OTSKY expected on 7/24 – Drug Centanafadine (NDA).

Novel norepinephrine/dopamine/serotonin reuptake inhibitor (NDSRI) for ADHD in children, adolescents, and adults (first-in-class non-stimulant option). --MNKD expected on 7/26 – Drug FUROSCIX ReadyFlow Autoinjector (sNDA/SCP-111).

Alternative delivery (autoinjector) of furosemide (diuretic) for edema in adults with chronic heart failure or chronic kidney disease. --OTLK expected on 7/29 - ONS-5010 / LYTENAVA (bevacizumab-vikg; BLA).

Biosimilar/reference bevacizumab for wet age-related macular degeneration (AMD). --VTRS expected on 7/20 - low-dose estrogen weekly patch (NDA).

Contraceptive patch.