NMIBC
Oct 08, 2024
OPDIVO Approved for Resectable NSCLC; Palvella Gets $2.6M FDA Grant; First Patient Dosed in UGN-103 Bladder Cancer Trial; Recordati Acquires ENJAYMO for $825 Million; AIRSUPRA Reduces Severe Asthma Exacerbations
FDA Approves Perioperative OPDIVO Plus Chemotherapy for Resectable NSCLC The FDA has granted approval to Bristol Myers Squibb’s OPDIVO (nivolumab) for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC), specifically targeting tumors that are 4 cm or larger or node-positive and hav...
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Aug 30, 2024
NMIBC Treatment Paradigm Evolution: A Look At The Clinical Development Shift From High-Risk Bcg Unresponsive To Untapped High-Risk Bcg Naïve And Intermediate-Risk NMIBC
A high cure rate characterizes Non-muscle Invasive Bladder Cancer (NMIBC), yet there is a notable risk of recurrence and progression to muscle-invasive disease. Effective NMIBC management involves precise local resection, staging, and a risk-based approach with intravesical agents. The conventional gold standard fo...
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Aug 26, 2024
Imbalance Between BCG Supply and Increased Demand: The Crisis Impacting Bladder Cancer Treatment
The BCG vaccine, a significant medical breakthrough developed in the early 20th century, is derived from a strain of Mycobacterium bovis initially created by the University of Illinois as a vaccine against tuberculosis. For NMIBC, BCG is administered intravesically to reduce the risk of cancer recurrence and progre...
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Apr 01, 2024
Advances in Non-Muscle Invasive Bladder Cancer Treatment: Exploring Emerging Therapies
Non-muscle-invasive bladder cancer represents a category of bladder cancer where the tumor is confined to the innermost layer of the bladder lining without invading the muscle. This early-stage form accounts for a significant proportion of bladder cancer cases. Among the 7MM, the US accounted for the highest num...
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May 09, 2023
FDA Approves GSK’s Arexvy for RSV; CHMP’s Opinion on Gilead’s Hepcludex® for HDV; FDA Clearance to ProMIS’s IND Application for PMN310; FDA Grants 501K Clearance to Bladder EpiCheck; PharmaTher Submits Fast Track Application for Ketarx to US FDA; Fast Track Designation to Vedanta Biosciences’ VE303
FDA Approves GSK’s Arexvy, the First RSV Vaccine for Older Adults GSK plc stated that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by a respiratory syncytial virus (RSV) in peopl...
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Dec 20, 2022
Fourth FDA Approval for AbbVie’s Vraylar; FDA Approves Ferring’s Adstiladrin for NMIBC; Merck and Moderna’s mRNA Cancer Vaccine Trial; EMA Recommends the CSL’s Gene Therapy for Hemophilia B; CHMP Backs Amicus’ Pompe Disease Therapy; Takeda Announces the Phase 3 AURORA Study Result
AbbVie Secures Fourth FDA Approval for Vraylar AbbVie has received its fourth FDA approval for Vraylar, adding major depressive disorder (MDD) adjunctive therapy to a list that includes schizophrenia and manic and depressive episodes in bipolar disorder. According to AbbVie, the approval makes Vraylar (cariprazi...
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