The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA ... any action on the basis ...

The removal of the mandatory drug and neuropsychological testing applies exclusively in the application of the Philippine National Police (PNP) personnel of a new or renewal of license to own and ...

The proposed guidance aims to provide a framework for the approval of personalised mRNA-based cancer vaccines.

The contents section serves as a navigational ... products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced ...

With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...

Life sciences trends 2025 include the rise of personalized therapies, supply chain resilience, compliance, and collaboration ...

This content is produced by a team of seasoned ... based primarily on US drug approvals and applications. New drug monographs are created following approval of such drugs by the US Food and ...

Explore the distinctions between Generative AI and Agentic AI. Understand how each works, their use cases, limitations, and ...

Raritan: Johnson & Johnson has announced it has initiated the submission of an original New Drug Application with the U.S. Food and ... he proofreads and verifies all the medical content published on ...

Pharma and medtech companies are invited to join a project on PFAS exposure, emissions and end-of-life management in the ...