Sanofi secures two breakthrough nods in China for rare blood disorders

Qfitlia is the first antithrombin (AT)-lowering therapy approved for routine prophylaxis in hemophilia

Neuren partner Acadia bags FDA go-ahead for new DAYBUE STIX powder for Rett Syndrome

The new powder formulation gives children and adults living with Rett syndrome greater flexibility and choice in dose volume and taste

Zenas BioPharma and InnoCare hit key milestone in Lupus drug trial, secures China Phase 3 nod

The study also showed a clear dose-dependent trend, with the 75 mg QD group outperforming the 50 mg QD cohort

FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483

Lilly drug cuts risk of cancer progression, extends survival in advanced breast cancer trial

Updated results from the EMBER-3 study showed that the drug -- Inluriyo (imlunestrant) -- as a standalone treatment cut the risk of progression or death by 38%

EMA backs higher-dose Wegovy, clearing path for greater weight loss option in Europe

EMA backs Eylea 8 mg for retinal vein occlusion

The positive CHMP opinion is supported by results from the Phase III QUASAR trial

FDA fast-tracks first drug nod under new national priority voucher program

The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals

Shilpa Medicare receives initial authorization for Rotigotine transdermal patch from Europe

This is the first approval of a prescription transdermal dosage Form in the European markets from this facility

Granules Life Sciences facility receives EIR from USFDA

This approval confirms the facility's compliance with FDA quality standards and regulatory requirements