The FDA is signaling a lighter-touch approach to interchangeability as analytical science advances, while device-design, human-factors and product-specific uncertainties remain key development ...

Animal test” and “animal study” will be replaced with “nonclinical test” and “nonclinical study” in several regulations as ...

HHS announcements of “agency-wide actions” on reducing animal testing includes closing NIH’s last beagle laboratory and more ...

Withings is launching StethO Sense, a third-party service that analyzes cardiac and respiratory sounds in children and adults ...

Cosmetics will be a test case as the UK’s Office for Product Safety and Standards kicks off an initiative to foster ...

With successful Phase II/III data for laru-zova in X-linked retinitis pigmentosa, Beacon hopes it can bring the first drug ...

Reset Health shared data showing its Roczen platform could improve GLP-1 adherence as NICE asks the company and its competitors to prove their value to the NHS.

FDA says it’s “optimistic fostering the use of scientifically valid NAMs will lead to a reduced need for animal testing and to the use of fewer animals and of animals lower on the phylogenetic scale,” ...

Medtronic has secured FDA clearance for its LigaSure RAS Maryland instrument, adding vessel-sealing and cutting capabilities for minimally invasive urologic procedures to its Hugo robotic system.

The company reported results from the first of two Phase III clinical trials in bipolar mania, which could become the antipsychotic’s fifth US indication.

The redacted documents Public Citizen obtained via FOIA offered little information about many important provisions, such as the drugs covered, price setting process and overseas revenue flow back to ...

The company expects to initiate a Phase IIb/III registration trial testing the anti-IgE IgG1 antibody in CSU and a Phase II study in food allergy, based on the results of a Phase II trial in China.