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GDUFA IV: Fiscal Years 2028 – 2032

April 3, 2026
The FDA has initiated preparations for the fourth reauthorization of the Generic Drug User Fee Amendments (GDUFA IV), covering fiscal years 2028 to 2032. This reauthorization is crucial as it aims to enhance the efficiency of the generic drug approval process, which has significant implications for market access and competition in the pharmaceutical industry. As…

Lilly beefs up neuroscience pipeline with $6.3B Centessa buyout

April 3, 2026
In a strategic move to enhance its neuroscience portfolio, Eli Lilly has announced the acquisition of Centessa Pharmaceuticals for $6.3 billion. This deal secures two promising sleep disorder therapies, which are expected to address significant gaps in Lilly’s current offerings and bolster its competitive stance against established players such as Takeda and Eisai. The acquisition…

Novo Nordisk Introduces Subscription Model for Wegovy Weight Loss Treatments

April 3, 2026
On Tuesday, Novo Nordisk announced its innovative approach to selling Wegovy, its weight loss drug, by introducing a subscription model for its shots and pills. This move marks a significant shift in the pharmaceutical industry, where subscription services have been largely limited to consumer goods and digital platforms. This model could potentially reshape the landscape…

HHS Reverts Health IT Office Name and Focus to ONC

April 3, 2026
The U.S. Department of Health and Human Services (HHS) has officially reverted the name of its health IT office to the Office of the National Coordinator for Health Information Technology (ONC), a move announced earlier this week. This change also shifts the office’s focus back to external IT coordination, removing oversight of HHS’s internal technology…

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