Regulatory Approval

China approves Libevitug, a first-in-class drug for the most severe form of hepatitis, marking a major milestone for patients and global biotech innovation.

With drug pipelines facing staggering failure rates, HKeyBio's new preclinical strategy aims to de-risk R&D and accelerate effective new treatments.

A new study reveals albumin, the most abundant protein in blood, is a powerful weapon against mucormycosis, offering new hope for treating this fatal infection.

Myra Vision's Calibreye system, the first adjustable glaucoma shunt, has been implanted in a US patient, offering hope for personalized vision-saving therapy.

A new external bioengineered liver has passed a crucial safety trial, offering a potential lifeline for patients with acute liver failure.

A new intelligent oral appliance using biofeedback shows a massive reduction in sleep bruxism, offering hope to millions who suffer from jaw pain and headaches.

Insilico Medicine's AI-powered drug ISM8969, a brain-penetrant inhibitor, has been cleared by the FDA for clinical trials in Parkinson's disease.

Agilent's new S540MD scanner aims to tackle lab backlogs and boost diagnostic speed with high-throughput capacity and AI-powered automation.

A single patient with a debilitating eye pain condition gains access to an investigational therapy, offering hope where no approved treatments exist.

Swedish biotech innovator Hansa Biopharma wins a top award for its life-saving transplant tech, facing a pivotal year with FDA review on the horizon.

A new therapy for a rare blood cancer gets a major boost from the FDA, offering hope for thousands of myelofibrosis patients with limited options.

A novel, portable incubator has won FDA approval, offering a lifeline to premature babies in rural America by keeping families together and reducing costly transfers.

Health Canada acknowledges PetVivo's innovative Spryng joint treatment, paving the way for a new option for aging pets and athletic animals in Canada.

An innovative absorbable implant shows promise in helping men regain continence faster after prostate cancer surgery, a major quality-of-life concern.

A breakthrough liquid biopsy using '6-base genome' analysis shows unprecedented success in spotting Stage I colorectal cancer, promising to boost survival rates.

Ascletis Pharma unveils ASC37, a next-gen, once-monthly obesity drug claiming superior potency and convenience, challenging giants like Eli Lilly.

A novel cell therapy for Parkinson's earns a key FDA designation, signaling a potential paradigm shift from managing symptoms to reversing the disease.

At a major San Francisco summit, Chinese biotechs unveiled breakthrough heart and cancer drugs, signaling a strategic shift from manufacturing to global innovation.

Genmab's antibody drug epcoritamab is the first of its kind to slow cancer progression in a Phase 3 trial for R/R DLBCL, offering a new path for patients.

Prime Healthcare deepens its Chicago-area presence by acquiring Franciscan Health Olympia Fields, raising questions about consolidation and local care.