Luye Pharma Launches Erzofri in the US for Schizophrenia and Schizoaffective Disorder

Shots: Luye Pharma has launched Erzofri extended-release injectable suspension in the US to treat adults with schizophrenia & as monotx. or adjunct therapy for adults with schizoaffective disorder Erzofri was approved by the US FDA based on a multiple-dose, parallel-group study evaluating its PK profile & relative bioavailability at steady state vs reference product, demonstrating…

ByRidhi RastogiApril 7, 2025

Insights+: The US FDA New Drug Approvals in January 2023

Shots: The US FDA approved 8 NDAs and 1 BLA in January 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 9 novel products in 2023 In January 2023, the major highlights drugs were Rykindo (risperidone) approval for schizophrenia and bipolar 1 disorder, Brenzavvy (bexagliflozin) for type…

BySenior EditorFebruary 15, 2023

Insights+ Key Biosimilars Events of November 2022

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of November, Samsung Bioepis presented two P-III studies results…

BySenior EditorDecember 1, 2022

Luye Pharma Launches Erzofri in the US for Schizophrenia and Schizoaffective Disorder

Insights+: The US FDA New Drug Approvals in January 2023

Insights+ Key Biosimilars Events of November 2022

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