Drug Approval | November 23, 2025
FDA approves combo therapy for Cisplatin-ineligible muscle-invasive bladder cancer patients
The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy
The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy
The full approval is based on the results from the pivotal Phase 3 EPCORE FL-1 study
This marks Lupin’s first commercial product leveraging PrecisionSphere, a proprietary long-acting injectable (LAI) technology
This approval is based on positive results from two Phase 3, global, double-blind, placebo-controlled trials
Orphan drug designation (ODD) by the USFDA for Desidustat, provides eligibility for a potential seven-year marketing exclusivity subject to the USFDA approval
Kygevvi combines two pyrimidine nucleosides, doxecitine and doxribtimine, which act by integrating deoxycytidine and deoxythymidine into skeletal muscle mitochondrial DNA
This approval marks a significant milestone in women’s health, introducing Bayer’s first hormone-free treatment for menopause-related symptoms
Approval broadens indication for Tezspire to a second disease characterized by epithelial-driven inflammation
UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for use every one or two months for the treatment of schizophrenia in adults
Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study
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