Today, adoption of digital health faces some of the same barriers — scepticism, budget limitations, high expectations, and a ...

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

LONDON and NEW YORK - OKYO Pharma Limited (NASDAQ: OKYO), a biopharmaceutical company specializing in the development of treatments for ocular conditions and currently valued at $37 million, has ...

NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic NK cell therapeutics. NKGen is headquartered in Santa Ana, ...

GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...

Biohaven's NDA for Troriluzole was accepted by the FDA, potentially leading to approval in Q3 2025. Click here to find out ...

Twenty years ago, in 2004, Congress passed the Project BioShield Act, which established the Biomedical Advanced Research and ...

The FDA has made some modest efforts, but it needs an internal organization that understands and would be an aggressive ...

The Ghana Food and Drugs Authority (FDA) has spearheaded a joint initiative with National Regulatory Authorities (NRAs) in ...

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 ...

SAN FRANCISCO - Nektar Therapeutics (NASDAQ:NKTR) announced today that its drug candidate, rezpegaldesleukin, has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ...

Magdalena aiming to submit Investigational New Drug (IND) application in 2025 to the FDA for a next-generation psychoactive prescription drug candidate for potential mental health indications such as ...