European commercialization introduces an additional aflibercept biosimilar option for major retinal indications, potentially ...
Two Phase 3 multicenter trials of OCS-01 (OPTIREACH-enabled topical dexamethasone 15 mg/mL) missed 52-week BCVA and ≥15-letter gain endpoints, prompting abandonment of an FDA NDA for DME. Dosing ...
The resubmission follows a successful appeal by the company with the Office of New Drugs (OND). Outlook Therapeutics has resubmitted its Biologics License Application (BLA) to the US Food and Drug ...
FDA 510(k) clearance advances the FSYX OPAP platform beyond De Novo classification by incorporating wireless communication while maintaining a prescription-only, home-delivered therapy model. The ...
The FDR outcome directs FDA divisions to finalize labeling with the sponsor, reversing the prior CRL trajectory and ...
I began to chuckle as I realized the lesson dealt much more with the joys of getting an appointment, completing paperwork, ...
Researchers have developed a soft contact lens embedded with electrical stimulation electrodes that, in a mouse model of ...
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