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USC Roski Eye Institute Investigates Promising Drugs for TED
The USC Roski Eye Institute is making significant strides in the realm of Thyroid Eye Disease (TED) treatment through pioneering clinical trials exploring new medications. TED, a condition characterized by bulging eyes and potential vision impairment, has traditionally necessitated multiple…
Outlook Therapeutics Seeks UK Approval for Wet AMD Drug
Outlook Therapeutics announced the submission of its Marketing Authorisation Application (MAA) to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in a press release. The MAA is for bevacizumab gamma (ONS-5010/LYTENAVA), its investigational formulation of bevacizumab for the…
Rezolute’s Phase 2 Success with Oral DME Drug
Rezolute announced promising topline results from its Phase 2 clinical study of RZ402. This study targeted patients with diabetic macular edema (DME) who were either naïve to or had limited exposure to anti-vascular endothelial growth factor (anti-VEGF) injections. Monumental Results…
KDB GLIDE FDA 510(k) Clearance for Expanded Glaucoma Use
New World Medical announced a significant milestone with the receipt of 510(k) indication expansion from the U.S. Food and Drug Administration (FDA) for KDB (Kahook Dual Blade) GLIDE. This clearance allows for the reduction of intraocular pressure (IOP) in adult…
Clearside Biomedical Publishes SCS Delivery Guidelines
Clearside Biomedical has taken a significant step forward in the field of ophthalmology by publishing new guidelines for suprachoroidal space (SCS) injection, a technique used to deliver medication directly to the back of the eye. These guidelines have been featured…
China Grants Priority Review for Innovent’s TED Treatment NDA
Innovent Biologics announced that its New Drug Application (NDA) for their recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, IBI311, has been accepted and granted priority review designation by the Center for Drug Evaluation (CDE) of the China National Drug…
FDA Approves Biocon Biologics’ Yesafili™
Biocon Biologics today announced that the US FDA has approved the Company’s first-to-file application for Yesafili™ (aflibercept-jbvf), an interchangeable biosimilar aflibercept. Indications and Uses of YESAFILI YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor used to treat several ophthalmology conditions,…
Wayne State University Secures Grant for Diabetes Eye Study
Dr. Fu-Shin Yu, a professor of Ophthalmology, Visual and Anatomical Sciences at Wayne State University School of Medicine, has been awarded a significant grant from the National Eye Institute of the National Institutes of Health. The five-year grant, totaling $2,167,882,…
FDA Approves Glenmark’s Ophthalmic Solution for Glaucoma
Glenmark Pharmaceuticals has received final approval by the FDA for Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%|0.5% for glaucoma treatment. This solution has been recognized by the FDA as bioequivalent and therapeutically equivalent to Combigan® Ophthalmic Solution, 0.2%|0.5% by…
FDA Grants De Novo Authorization for Scanly Home OCT Device
Notal Vision announced that the FDA has granted De Novo authorization for its patient self-operated Scanly Home OCT device. Designated by the FDA as a breakthrough device for patients suffering from wet age-related macular degeneration (AMD), Scanly Home OCT aims…