The United States Food and Drug Administration (FDA) recently released a draft guidance, Expedited Program for Serious ...

In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) ...

This article explores how digital maturity in process design and parameter management can drive significant time and cost savings, streamline tech transfers and ultimately accelerate patient access to ...

The Food and Drug Administration granted fast track designation to AUTX-703 for relapsed or refractory acute myelogenous ...

Jeanne Shaheen, D-N.H., the ranking Democrat on the Appropriations Committee’s subcommittee on Agriculture, Rural Development ... They underscore that the FDA’s drug, device and tobacco ...

Diagnos Inc. (“DIAGNOS” or the “Corporation”) (TSX Venture: ADK, OTCQB: DGNOF, FWB: 4D4A), a pioneer in early detection of critical health issues through the use of its FLAIRE platform based on ...

Lundbeck has received the US FDA fast track designation for amlenetug, a potential treatment for multiple system atrophy (MSA ...

Initial feasibility study of its soluble, Ph neutral, fast acting granular or powder drug delivery system is complete ...

Drug development is an expensive and high-risk process. The median cost per approved drug can reach up to $2.8 billion, ...

Washington — Federal officials on Thursday approved a new type of pain drug designed to eliminate ... medication's modest effectiveness and lengthy development process underscore the challenges ...

No doubt 2025 will usher in many more advances in CRISPR therapies, thanks to the FDA’s new Platform Technology Designation ...

Sterotherapeutics, a leading biopharmaceutical company dedicated to advancing innovative therapies, is announcing the launch of a Phase 2 clinical trial for ST-002, a novel drug candidate for patients ...