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

Glenmark bags FDA nod for generic asthma inhaler with 180-day exclusivity

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

Caplin Steriles gets FDA approval for desmopressin

Desmopressin Acetate Injection is primarily used to treat central diabetes insipidus, haemophilia A, and von Willebrand disease

Zydus receives final approvals from USFDA for Ivermectin Tablets USP

Ivermectin Tablets USP, 3 mg, are prescription anti-parasitic medications primarily indicated for treating parasitic worm infections in humans