FDA approves Eli Lilly’s Inluriyo for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer

An estimated 50% of patients with ER+, HER2– metastatic breast cancer will develop an ESR1 mutation during or after exposure to an aromatase inhibitor

DINAMIQS inaugurates new cGMP viral vector manufacturing facility in Switzerland

The new site enables end-to-end production of viral vector gene therapies

Infinitus launches MCP server to bring standardized AI interoperability to healthcare

New infrastructure makes it possible for healthcare organizations to integrate AI agents seamlessly into critical workflows like benefit verification and prior authorization

FDA approves Alembic’s Paroxetine ER tablets

Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg, are indicated for the treatment of major depressive disorder

The Lancet Regional Health publishes pivotal phase 3 clinical study on Miqnaf

Pi Health to deliver clinical research services for GSK’s Phase 2 oncology trial

Physician-led Pi Health has demonstrated capabilities to dramatically reduce clinical trial timelines and administrative burden, while increasing data quality

Lupin receives FDA tentative approval for Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets

Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets are indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg

Dr. Reddy's receives positive CHMP opinion from EMA for denosumab 'AVT03'

Prolia is a prescription medicine used to treat osteoporosis in women

Max Hospital, Saket pioneers India’s first HDF certification program for Nephrologists

AstraZeneca’s Koselugo recommended for approval in the EU for Neurofibromatosis type 1

The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population