Aligos Therapeutics is heralding a midstage win in metabolic-dysfunction associated steatohepatitis (MASH) after three different doses of its drug candidate significantly slashed liver fat at 12 weeks. Despite the company’s enthusiasm, the results failed to impress investors.

Vanda Pharmaceuticals has failed to persuade the FDA to approve its gastroparesis candidate on the strength of a phase 3 trial that missed its primary endpoint. The biotech came out swinging after the knock-back, accusing the agency of sending a complete response letter that generally disregarded the evidence.

Medtronic is offering a peek into its ongoing, at-home trial of people with Parkinson’s disease being treated with adaptive deep brain stimulation, a technology that’s currently under review at the FDA.

GE HealthCare’s recently acquired MIM Software division has secured an FDA clearance for a tool to help quantify the density of amyloid plaque in the brains of people with Alzheimer’s disease.

Innovent Biologics has made the case that its checkpoint inhibitor-cytokine fusion protein has a future in colorectal cancer. A phase 1 trial that combined the drug candidate with Avastin reported a 21.9% response rate, including signs of efficacy in patients with liver metastases and prior immunotherapy use.

After pushing back the decision date for Applied Therapeutics’ metabolic disorder drug govorestat, the FDA has now decided that a planned advisory committee meeting won’t be required.

Much of the brain is made up of a constellation of star-shaped cells called astrocytes, which play vital roles in immunity, neuron maintenance and many other functions. In Alzheimer’s disease, some astrocytes serve as celestial guardians that break down the amyloid beta protein plaques that build up in the brain; others, however, go rogue, actually secreting amyloid beta themselves.

The FDA is getting the word out regarding a recall effort from Zimmer Biomet related to its discontinued CPT hip implant and its potential link to fractures of the thigh bone after placement.

Though Alkeus Pharmaceuticals’ oral eye disease asset failed to significantly reduce geographic atrophy (GA) lesion growth, the biotech is citing “clinically meaningful” results and a secondary endpoint win as reasons to pursue further development.

Five months after Rakovina Therapeutics pivoted toward artificial intelligence, the cancer-focused biotech has joined forces with Variational AI to identify new therapies against DNA-damage response (DDR) targets.