The FDA has launched a project with the Bill and Melinda Gates Foundation to help aid the development of breath-based diagnostics for detecting diseases more easily among underserved populations, including in rural, remote and impoverished areas.

Ethris’ mRNA-based treatment to prevent viral infections in people with uncontrolled asthma so far appears to be safe and increases expression of its target protein, early data suggest.

Silence Therapeutics has spoken up about its phase 1 polycythemia vera (PV) clinical trial, providing an early look at how its siRNA prospect may match up to rivals from Incyte and Takeda.

CalciMedica said it is “moving quickly” to take Auxora into phase 3 after the calcium release-activated calcium channel inhibitor was shown to reduce the time before solid food could be consumed by a subgroup of patients with hyperinflamed pancreatitis.

Six months after its due date, the FDA’s draft guidance for clinical trial diversity is finally here. The agency on June 26 issued a new outline of its proposed requirements for the racial and ethnic diversity action plans that will eventually be mandatory components of studies on drugs, devices and other medical products.

A death and other adverse events have forced Lyell Immunopharma to take a two-track approach to its early-phase CAR-T clinical trial, holding back dose escalation in people with lung metastases while racing ahead in the wider population.

Intellia Therapeutics doesn’t need to re-dose patients with a CRISPR gene edited therapy for transthyretin (ATTR) amyloidosis. But new data suggests it could be done.

What if a major transplant surgery could have the same convenience as an outpatient procedure? Surgeons at Northwestern Medicine now have a better idea of the potential benefits after delivering a new kidney without using general anesthesia—and being able to discharge the patient the next day.

Endotronix has secured an FDA approval for its early warning sensor implant to remotely track patients with serious and potentially worsening heart failure.

Eli Lilly is teaming up with OpenAI on a quest to develop new treatments that overcome antimicrobial resistance (AMR).