USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru

The inspection concluded successfully, with the facility found to be in compliance with the required regulations

FDA approves AbbVie’s mavyret as first and only treatment for acute hepatitis C

Now approved for both acute and chronic HCV in adults and children aged 3 and above

USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad

The company received 1 (One) observation in the Form-483

FDA approves Merck’s enflonsia for prevention of RSV in infants

Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months

Lupin receives tentative approval from USFDA for Oxcarbazepine ER Tablets

Oxcarbazepine ER Tablets (RLD Oxtellar XR) had estimated annual sales of US$ 206 million in the US (IQVIA MAT April 2025)

Linerixibat new drug application accepted for review by the USFDA for cholestatic pruritus in patients with PBC

If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference

Zydus receives tentative approval from USFDA for Rifaximin Tablets, 550 mg

Rifaximin tablets had annual sales of US$ 2672.9 mn in the United States (IQVIA MAT March 2025)

Piramal Pharma completes USFDA inspection of Aurora facility with Zero Form-483 observations

Zydus receives USFDA ‘Fast Track Designation’ for novel oral inhibitor ‘Usnoflast’

Usnoflast has previously also received ‘Orphan Drug Designation (ODD)’ from the USFDA

Bayer’s Sevabertinib granted FDA priority review for the treatment of patients with HER2-mutant non-small cell lung cancer

This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition