Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial

Wockhardt submits drug application to FDA for Zidebactam-Cefepime for treatment of serious Gram-negative infections

This milestone marks the first-ever NDA submission to the U.S. FDA for a drug, fully discovered and developed by an Indian pharmaceutical company

Lupin receives FDA approval Rivaroxaban for oral suspension

The product will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India

Biocon Biologics secures US market entry date for Bosaya and Aukelso, Denosumab biosimilars

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

FDA approves Lupin’s Lenalidomide capsules

Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma

Biocon Biologics receives FDA approval for Bosaya and Aukelso biosimilars

Senhwa Biosciences’ Pidnarulex joins forces with global PD-1 leaders to advance next-gen immunotherapy

This strategic collaboration represents the third clinical trial under Senhwa’s five-year NCI-sponsored cancer research program

Biocon inaugurates first US manufacturing facility in New Jersey

FDA grants Fast Track Designation for Teva’s Emrusolmin

Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development