Initial module submission marks an important milestone in the pre-market approval process - - Flexible modular submission ...

The US Food and Drug Administration has missed its latest deadline to propose banning formaldehyde and certain ...

Receiving these important FDA designations and invitation to participate in the CDRP program highlights the significant unmet need among pediatric patients with LMs and underscores our belief that ...

M+ cash runway to 2029, bitopertin FDA NDA/accelerated approval catalyst, and DISC-0974 myelofibrosis data—read now.

The "Human Factors and Usability Engineering in the Development of Drug Delivery Products Training Course (Feb 11th - Feb 12th, 2026)" training has been added to ResearchAndMarkets.com's offering.

CapsoVision, Inc. CV recently announced that it has submitted a 510(k) application to the FDA for approval to add an AI-based ...

MDR, MDSAP, and FDA audits demand rigorous preparation, lifecycle traceability, and risk-based compliance for global market ...

Between exiting the Smiths remediation process, leveraging new product introductions (and overhead leverage), and ...

The FDA has qualified its first artificial intelligence tool to help drug developers evaluate fatty liver disease in their clinical trials. The agency gave a green light to the AI-Based Histologic ...

Innovation drives speed in early phase drug development. ICON’s Accelerated Pharmaceutical Solutions integrate advanced formulation design, real-time dose flexibility, and cutting-edge CMC expertise ...

The Food and Drug Administration has launched web versions of four forms for companies submitting or amending tobacco product applications. The forms, part of the agency’s upgraded CTP Portal Next ...