The Council has formally adopted its position on the EU pharmaceutical package, moving the bloc's largest overhaul of medicines legislation in decades toward its final legislative stages.

EU pharmaceutical legislation has moved closer to completion after member states backed the Council's first-reading positions on the regulation and directive forming the bloc's revised medicines framework.

Medovate and JEB Technologies are combining into a single medical-device company under the Medovate name, integrating product development, manufacturing, regulatory and commercial capabilities.

The latest regulatory package is intended to reduce uncertainty, development costs and delays for generic manufacturers as the US government increases pressure to bring lower-cost medicines to patients more quickly.

The company has expanded its US clinical validation study to support a future FDA submission for its adult NGAL kidney injury test while continuing to grow adoption of the biomarker in clinical practice.

The discussion paper launches a public consultation that could shape future regulatory expectations for AI-enabled medical devices, including premarket evaluation, risk assessment and postmarket monitoring.

The submission seeks approval for a next-generation mitomycin formulation designed for intravesical treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, building on the same drug-delivery platform as FDA-approved Zusduri.

The new tool is intended to help health technology developers determine whether a medicinal product falls within the EU’s Joint Clinical Assessment requirements before entering the formal HTA process.

The EU Health Technology Assessment Regulation now requires eligible oncology medicines and advanced therapies to undergo a single European clinical assessment, increasing the importance of early evidence planning alongside EMA regulatory development.

The draft guidance could reduce reliance on animal studies for some oncology products while increasing the importance of analytical characterisation and weight-of-evidence approaches during development.

Recent legal and regulatory developments could influence how innovative medicines are protected in Europe by changing the interaction between regulatory exclusivity, patent rights and generic market entry.

Healthcare organisations and technology developers face an expanding mix of state laws, sector-specific FDA expectations and federal policy initiatives rather than a single nationwide AI regulatory framework.

The guidance gives sponsors clearer recommendations for addressing trial design, safety monitoring, abuse potential and the operational challenges associated with hallucinogenic drug effects.

The US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) have announced a new formal collaboration initiative