As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review ...

Magdalena aiming to submit Investigational New Drug (IND) application in early 2025 to the FDA for a next-generation ...

Pluristyx Announces Immediate Availability of GMP-Compliant PSXi013 iPSC Line for Advanced Therapy Development ...

Breakthrough Therapy Designation granted based on key positive data from the Phase 2b (RIZE) study and current unmet medical need in congenital ...

Variant Bio, a small biotech company based in Seattle, is using genetic information from Indigenous people to develop drugs ...

By combining diverse datasets and powerful analytical and modeling tools, drug developers are finding more potential ...

Medical-device maker Stryker on Monday agreed to acquire Inari Medical , which makes devices that treat patients with venous ...

Among the hundreds of thousands of chemical compounds produced by plants, some may hold the key to treating human ailments and diseases. But recreating these complex, naturally occurring molecules in ...

Because of the risks biopsies can pose to patients, the FDA recommends only requiring them as part of trial participation if ...

A line-up of experts across academia, pharma, and healthcare came together to discuss the impact and challenges of ...

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Nitroxoline has not been approved by the FDA, and its use is therefore considered investigational. FLA patients will receive ...