Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

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

BMS’s anti-MTBR-Tau granted fast track designation by FDA for Alzheimer’s disease

Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of disease

FDA issues CRL for Sentynl’s copper histidinate for treatment of Menkes disease

FDA grants De Novo classification to first needle-free, glucose sensor Biolinq Shine

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

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

Leqembi wins NMPA nod for once-monthly IV dosing in early Alzheimer’s patients

LEQEMBI was initially approved in China in January 2024 for the treatment of Alzheimer’s disease in patients with mild cognitive impairment

FDA authorizes first eyeglass lenses to slow progression of pediatric Myopia

FDA authorization was based on two years of clinical study data demonstrating that Essilor Stellest lenses significantly slowed myopia progression compared to single-vision control lenses

AstraZeneca to harmonise its listing structure across LSE, STO and NYSE

Harmonisation of listing structure requires a direct listing of AstraZeneca shares on the NYSE in place of existing US ADRs

European Commission approves Lilly’s Kisunla for treatment of early Alzheimer’s patients