Drug Approval | January 08, 2026
Bayer’s Sevabertinib gets green light from FDA and China for advanced lung cancer
Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations
Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) that directly targets HER2 mutations
The investigational subcutaneous hepcidin mimetic peptide is designed to regulate iron and red blood cell production
The MAGiC catheter is designed for robotically-navigated cardiac ablation procedures
The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety
WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation
Currently approved for patients eight and older, Tzield could now be used to delay the onset of stage 3 type 1 diabetes (T1D) in children diagnosed with stage 2 T1D
The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation
The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence
Theracor is derived from human umbilical cord extracellular matrix (ECM) and is designed to cover, protect, and maintain a moist wound environment
The Toumai platform, currently the only robotic system with US FDA Study Approval for telesurgery, enabled real-time surgical control with no compromise to patient safety
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