Watch this critical discussion on how regulators and biotech companies can bridge the expectation gap during the regulatory ...

As FDA itself observes, “devices of a new type that FDA has not previously classified … are ‘automatically’ or ‘statutorily’ classified into class III…, regardless of the level of risk they pose.” To ...

In another development, 25 states have petitioned to join a lawsuit and defend the EPA’s decision to rescind the climate ...

Accelerated approval of semaglutide 7.2 mg establishes a higher-dose, once-weekly GLP-1 RA option for long-term weight ...

A cannabinoid drug candidate for the treatment of Autism Spectrum Disorder is being explored by in trials, led by Ajna BioSciences, Charlotte's Web, and British-American Tobacco in a joint venture ...

The Food and Drug Administration has announced some major changes to the review process for drug developers in the United States. It could cut down the time from 10 to 12 months for a review to just ...

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

NEW YORK, March 25, 2025 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) (“INBS” or the “Company”), a medical technology company delivering intelligent, rapid, non-invasive testing ...