As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review ...

New FDA draft guidance for drugmakers focuses on trial design for developing obesity treatments. Read more here.

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 hyperinsulinism (HI) Ersodetug continues to advance in ...

Alleviant Medical announced that it received FDA investigational device exemption and breakthrough device designation for its ...

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 ...

Neurizon Therapeutics recently received EMA orphan designation for NUZ-001 to treat ALS and filed an FDA IND application to ...

Researchers at the University of Oklahoma have developed a breakthrough method of adding a single nitrogen atom to molecules, ...