New FDA draft guidance for drugmakers focuses on trial design for developing obesity treatments.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

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

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

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

In the world of drug development, the timing and design of clinical trials can be crucial in getting a new drug to market ...

Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy ...

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

The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell ...