FDA completes inspection at Biocon Biologics' facility in Bengaluru

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

Resolution Therapeutics doses first patient in phase I/II Emerald study of RTX001 for end-stage liver disease

RTX001 represents a groundbreaking advance in the treatment of end-stage liver disease, offering new hope for patients with limited options

Sanofi’s amlitelimab met all primary and key secondary endpoints in the COAST 1 phase 3 study in adults and adolescents with atopic dermatitis

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

Merck’s oral PCSK9 inhibitor Enlicitide shows promising results in phase 3 CORALreef lipids study

Enlicitide achieved all primary and key secondary endpoints, demonstrating statistically significant and clinically meaningful reductions in low-density lipoprotein cholesterol

FDA approves Lecanemab autoinjector, marking first at-home treatment for Alzheimer disease

The new subcutaneous autoinjector for lecanemab offers a self-administered, at-home treatment option for early-stage Alzheimer's disease

Roche, Alnylam to initiate Phase 3 cardiovascular outcomes trial of zilebesiran

Zilebesiran, a potential best-in-disease RNAi anti-hypertensive with twice-yearly subcutaneous dosing, demonstrated encouraging safety when combined with two or more antihypertensives

Bayer presents Phase III VICTOR clinical trial data of vericiguat at ESC Congress 2025

The positive benefit-risk profile of vericiguat in its approved indication in patients with HFrEF following a recent heart failure event based on the pivotal Phase III VICTORIA trial remains unchanged

MHRA approves UK’s first new type of antibiotic for urinary tract infections

As with any medicine, the MHRA will keep the safety of gepotidacin under close review

Lilly's Verzenio scores first OS improvement in breast Cancer

Treatment with Verzenio also resulted in sustained invasive disease-free survival and distant relapse-free survival benefit