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New FDA Bonus Pilot Program Aims to Alleviate Workforce Challenges

March 23, 2026
A new bonus pilot program designed to incentivize fast-working FDA reviewers will be partially funded by industry user fees, as outlined by Commissioner Marty Makary. This initiative comes in response to ongoing workforce challenges within the agency, which have been exacerbated by increasing demands for timely drug approvals and regulatory oversight. The context of this…

HHS Proposes Treating Patient Health Data as a Public Utility

March 23, 2026
Last year, the Department of Health and Human Services (HHS) released a comprehensive document outlining its strategy for real-world data utilization. Traditionally, health and biomedical data has been generated through meticulously controlled clinical trials. However, in an increasingly digital landscape, this data can be extracted from the everyday interactions patients have with the healthcare system,…

Upperton Submits MHRA License Application for Annex 1 Sterile Manufacturing Facility Following APS Validation

March 23, 2026
Upperton has submitted its application to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the approval of its new 7,000 sq. ft sterile manufacturing facility. The submission follows the successful execution of multiple aseptic process simulations (APS media-fill batches), completed in accordance with the revised EU GMP Annex 1 (2023) requirements. The sterile…

Lilly targets employers in new bid to broaden access to obesity drugs

March 23, 2026
A service tailored to people with workplace-based insurance coverage represents a new way for Lilly to bypass insurers and expand use of its popular obesity shot. By directly engaging employers, Lilly aims to increase accessibility for employees who may struggle to obtain these medications through traditional insurance channels. This strategic move highlights the growing trend…

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