FDA nod to LifeVac De Novo, paving for next-generation anti-choking device

The FDA classified LifeVac as a Class II medical device

Roche reports Phase III persevERA breast cancer trial results

Giredestrant shows promise despite missing primary goal

Mosaic Clinical Technologies’ AI breakthrough earns FDA “Breakthrough Device” designation

Cognita CXR leverages a proprietary vision-language model to analyze full chest X-ray studies and generate comprehensive preliminary findings

Neuland to launch commercial peptide facility in Hyderabad as global capacity tightens

The first of four planned modules at the new plant is expected to come online by summer 2026

FDA nod to groundbreaking combo therapy for relapsed multiple myeloma

This new treatment option can redefine how we approach RRMM treatment by giving healthcare providers a regimen with improvement in PFS and OS and a well-characterized safety profile

FDA okays JUXTAPID for kids with ultra-rare genetic cholesterol disorder

Teva and Blackstone Life Sciences strike $400m deal to advance promising IBD therapy

The funding will be spread over four years, with BXLS also eligible for regulatory and commercial milestones, plus royalties on worldwide sales

FDA nod to YUVIWEL, first once-weekly treatment for kids with achondroplasia

Achondroplasia, a rare genetic disorder, causes skeletal dysplasia and often increases the risk of muscular, neurological, and cardiorespiratory complications

Lupin receives EIR from FDA for its Goa facility

The EIR was issued following an inspection of the facility from November 10 to November 21, 2025

FDA nod to Boehringer Ingelheim’s first-line therapy for HER2-mutant lung cancer

Zongertinib is setting a new standard as the first targeted therapy for treatment naïve patients with HER2-mutant advanced non-small cell lung cancer with demonstrated efficacy