Briefs: Zydus and CuraTeQ Biologics

CuraTeQ Biologics receives approval for biosimilar Zefylti from UK’s MHRA

Lupin launches Tolvaptan Tablets in the US with 180-day exclusivity

Tolvaptan Tablets are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease

Sigachi Industries receives CEP for Metformin Hydrochloride from EDQM

The CEP certification for Metformin Hydrochloride aligns with the company's strategy to penetrate stringently regulated markets

Senores Pharmaceuticals acquires ANDA for Topiramate HCl 25, 50, 100 and 200 mg tablets

Topiramate is indicated as a treatment of epilepsy and migraine

Morepen to launch new fatty lever drug ‘Resmetirom’

FDA approves Medtronic’s new Simplera Sync sensor for the MiniMed 780G system

The Simplera Sync is a disposable, all-in-one sensor that requires no fingersticks with SmartGuard

Rockwell Automation empowers NKP Pharma achieve regulatory compliance

By integrating Rockwell Automation’s FactoryTalk Optix, NKP Pharma has achieved compliance with USFDA 21 CFR Part 11

Biocon Biologics secures market entry date for Yesafili in US

YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor, is used to treat several different types of ophthalmology conditions

Aurobindo receives final ANDA approval for Rivaroxaban Tablets USP, 2.5mg

The product will be launched in Q1FY26

FDA approves Opdivo plus Yervoy as treatment metastatic colorectal cancer

The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date