FDA nod to first treatment for rare genetic brain disorder

The approval comes after a systematic review of published literature

FDA nod to Bristol Myers Squibb’s Sotyktu as new oral therapy for psoriatic arthritis

The FDA decision was based on results from the pivotal POETYK PsA-1 and POETYK PsA-2 Phase 3 trials

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

FDA grants priority review to Enhertu for high-risk HER2-positive breast cancer

Enhertu recently received Breakthrough Therapy Designation, accelerating development and review for this critical patient population

Lupin receives two observations from USFDA for Ankleshwar facility

The company will address the observations and respond to the U.S. FDA within the stipulated timeframe

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

Bayer expands MRXperion power injector capabilities with FDA nod

The system also introduces Imaging Scanner Interface 2 (ISI2) capability, enabling direct communication between injector and scanner to improve exam coordination and operational efficiency

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

Granules India’s US packaging facility clears FDA inspection with zero observations

The inspection concluded with zero observations, confirming the facility's compliance with current Good Manufacturing Practices

Esperion to acquire Corstasis, gaining first FDA-approved nasal spray Diuretic