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

FDA completes inspection at Biocon Biologics' facility in Bengaluru

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

AstraZeneca’s Baxdrostat proves effective in in Phase III trial for hard-to-control hypertension

The medicine was well tolerated, with no unexpected safety issue

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

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

Glenmark Pharmaceuticals USA to launch Eribulin Mesylate injection

Glenmark’s Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials is bioequivalent and therapeutically equivalent to the reference listed drug, Halaven Injection, 1 mg/2 mL (0.5 mg/mL),of Eisai

Apitoria Pharma receives 5 observations from USFDA for API facility

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported

FDA suspends Valneva’s license of chikungunya vaccine IXCHIQ in US

The sudden subsequent decision to suspend IXCHIQ is based on updated VAERS data

Novo Nordisk’s Wegovy cuts risk of heart attack, stroke or death by 57% compared to tirzepatide

The study showed a significant 29% reduction in the risk for heart attack, stroke and death from any cause in the Wegovy users