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814 News Found

Pharvaris’ deucrictibant shows rapid relief for hereditary angioedema in pivotal Phase 3 trial
Clinical Trials | December 09, 2025

Pharvaris’ deucrictibant shows rapid relief for hereditary angioedema in pivotal Phase 3 trial

The study met its primary endpoint and all 11 secondary efficacy endpoints


B Braun unveils ready-to-use antibiotic system
R&D | December 08, 2025

B Braun unveils ready-to-use antibiotic system

DUPLEX’s two-compartment, PVC- and DEHP-free design keeps medication and diluent separate until activation


Bayer reports promising results for low-dose pediatric MRI contrast agent
Clinical Trials | December 07, 2025

Bayer reports promising results for low-dose pediatric MRI contrast agent

MRI is particularly valuable in pediatric care due to its non-invasive nature


Senores Pharmaceuticals receives Philippine FDA approval for 10 products
Drug Approval | December 05, 2025

Senores Pharmaceuticals receives Philippine FDA approval for 10 products

Senores Pharmaceuticals is poised to accelerate its presence in the Asia-Pacific region


Ascendis Pharma’s FDA review of Achondroplasia drug gets 3-month delay
Drug Approval | November 30, 2025

Ascendis Pharma’s FDA review of Achondroplasia drug gets 3-month delay

The FDA has classified recent submissions as a major amendment pushing the approval to its NDA for TransCon CNP back three months to February 28, 2026


India becomes first country to approve STIMULAN Rapid Cure with antifungals
Medical Device | November 26, 2025

India becomes first country to approve STIMULAN Rapid Cure with antifungals

Surgical site infections and antimicrobial resistance remain major challenges globally


FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures
News | November 24, 2025

FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures

Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels


FDA investigates fatal case linked to rare blood disorder drug Adzynma
News | November 24, 2025

FDA investigates fatal case linked to rare blood disorder drug Adzynma

Adzynma, approved for both adults and children with cTTP, is a recombinant enzyme therapy designed to replace the deficient ADAMTS13 enzyme


Alvotech and Advanz Pharma secure European nod for Gobivaz, first biosimilar to Simponi
Drug Approval | November 24, 2025

Alvotech and Advanz Pharma secure European nod for Gobivaz, first biosimilar to Simponi

Gobivaz is authorised for adults with rheumatoid arthritis (in combination with methotrexate), psoriatic arthritis (with or without methotrexate), axial spondyloarthritis, and ulcerative colitis


Dr Reddy’s receives EU nod for AVT03 biosimilar denosumab
News | November 24, 2025

Dr Reddy’s receives EU nod for AVT03 biosimilar denosumab

AVT03 is a biosimilar of Amgen's Prolia (denosumab 60 mg/mL) and Xgeva (denosumab 70 mg/mL), which are used to treat various bone conditions