GSK’s Exdensur wins Japanese nod for severe asthma
The approval follows robust data from the SWIFT and ANCHOR Phase III trials
The approval follows robust data from the SWIFT and ANCHOR Phase III trials
Mepolizumab is the first and only monthly biologic in China tested for COPD patients with blood eosinophil counts (BEC) as low as 150 cells/µL
The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation
Syrma Johari is a globally recognised medical device engineering and manufacturing organisation
The trials did not show a statistically significant reduction in annualized clinical fracture rates compared to placebo or bisphosphonates
Intas becomes the first and only company in India to offer IVF and gynecology therapies with needle-free injections
According to IQVIA sales data for the 12-month period ending October 2025, the Epinephrine Injection USP, 30 mg/30 mL (1 mg/mL) market2 achieved annual sales of approximately $67.6 million
The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,
The approval for Exdensur (depemokimab-ulaa) comes on the back of SWIFT-1 and SWIFT-2 Phase III trials
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