Celltrion gets Health Canada nod for Eylea biosimilar Eydenzelt

Health Canada’s approval was based on a comprehensive evaluation of analytical, nonclinical, and clinical data

FDA rejects Regeneron’s Eylea HD pre-filled syringe application amid manufacturing setbacks

European Commission approves Eylea 8 mg with extended 6-month treatment interval for nAMD and visual impairment due to DME

Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with nAMD and DME

Long-term efficacy and safety profile of Eylea 8 mg with extended dosing intervals in diabetic macular edema confirmed at three years

Results from the open-label extension study of PHOTON demonstrate patients with diabetic macular edema (DME) randomized to Eylea 8 mg maintained visual and anatomic improvements at the end of three years

Amgen confident in US biosimilar market’s strength as sales surge 52%

Biocon Biologics’ retinal disorder medication Yesafili gets public funding in Canada

Yesafili, available in vial and prefilled syringe presentations (2 mg/0.05 mL), was the first biosimilar to Eylea approved by Health Canada

Biocon Biologics receives Health Canada approval for Yesafili

The approval is based on a comprehensive package of analytical, nonclinical, and clinical data

Bayer confirms 2025 targets after solid start to the year

EBITDA before special items decreases to €4.08 billion (7.4%)

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

Bayer’s pharma growth strategy progressing well as pipeline advances

Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid