Alembic gets FDA final approval for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe

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

USFDA conducts product specific pre-approval inspection at Lupin’s Aurangabad facility

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

FDA approves sBLA for Takeda's Vonvendi for Von Willebrand disease

Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD

Zydus Lifesciences gets 4 USFDA observations for Jarod Injectable facility

Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner

FDA completes inspection at Biocon Biologics' facility in Bengaluru

The U.S. FDA issued a Form 483 with five observations

FDA expands medtronic MiniMed 780G system

Now integrates with Abbott’s instinct sensor and approved for type 2 diabetes

Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity

This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity

Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA

Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure

FDA grants accelerated approval to Zongertinib for HER2-mutated non-squamous NSCLC

New targeted therapy offers hope for patients with unresectable or metastatic NSCLC harboring HER2 tyrosine kinase domain activating mutations