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India's CDSCO Grants Regulatory Approval for Takeda’s Qdenga Dengue Vaccine
The Central Drugs Standard Control Organisation (CDSCO) has officially authorized the marketing of Qdenga, a dengue tetravalent vaccine manufactured by Takeda, marking a significant development in India’s public health strategy. The approval introduces the first preventative immunologic tool against dengue fever in the country. This regulatory milestone follows a comprehensive evaluation of the vaccine’s safety, quality, and efficacy under the provisions of the Drugs and Cosm
Badari Andukuri
Jul 21
CMS Outlines Operational Path for 2028 Maximum Fair Price Compliance
On July 16, 2026, the Centers for Medicare & Medicaid Services (CMS) issued a new draft guidance that fills in critical operational details for the Inflation Reduction Act’s drug price negotiation program. The document explains how pharmaceutical manufacturers will be expected to implement Medicare’s negotiated prices when they go live in 2028, with specific expectations for both pharmacy-dispensed and physician-administered therapies. For life sciences companies, this guidan
Badari Andukuri
Jul 20
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