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UK MHRA approves phase 2a study for ANXV for diabetic retinopathy

(Image credit: AdobeStock/Janis Smits) UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the start of a clinical Proof of Concept phase 2a study with the drug candidate ANXV in the eye disease diabetic retinopathy (DR). Patients with newly…

Glaukos Submits FDA Application for Epioxa Therapy

Glaukos Corporation has officially submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its innovative corneal cross-linking therapy, Epioxa (Epi-on). This next-generation treatment is designed for patients with keratoconus and represents a significant advancement…

Opus Gets FDA SPA for APX3330 Phase 3 Trial

Opus Genetics has announced a key regulatory milestone, securing a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) for its Phase 3 clinical trial of APX3330. The oral treatment is being evaluated for moderate to…

EYLEA HD Succeeds in Phase 3 RVO Trial

Regeneron Pharmaceuticals has announced that its Phase 3 QUASAR trial evaluating EYLEA HD (aflibercept 8 mg) has met its primary endpoint, marking a significant advancement in the treatment of retinal vein occlusion (RVO). About the QUASAR Trial The QUASAR trial…

Aurion’s AURN001 Shows Positive Phase 1/2 Results

Aurion Biotech has released topline data from its Phase 1/2 clinical trial (CLARA), evaluating AURN001, an allogeneic cell therapy product candidate for treating corneal edema secondary to corneal endothelial dysfunction. These results highlight the therapy’s potential as a groundbreaking treatment…

FDA Clears ViGeneron’s VG801 for Stargardt Disease

The U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for VG801, ViGeneron’s novel gene therapy candidate designed to treat Stargardt disease and other retinal dystrophies caused by mutations in the ABCA4 gene. This marks…

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