TearSolutions, Inc. has announced that the FDA has granted both Orphan Drug Designation (ODD) and Fast Track Designation for ...
European commercialization introduces an additional aflibercept biosimilar option for major retinal indications, potentially ...
I began to chuckle as I realized the lesson dealt much more with the joys of getting an appointment, completing paperwork, ...
In inflamed corneal cells, NADPH repletion occurred within 30 minutes, accompanied by ROS suppression and immune-cell ...
The FDR outcome directs FDA divisions to finalize labeling with the sponsor, reversing the prior CRL trajectory and ...
Central epithelial nerve fiber density and related architectural metrics remain profoundly reduced up to two years post-LASIK, with parallel increases in mechanical (but not osmotic) sensory ...
Researchers have developed a soft contact lens embedded with electrical stimulation electrodes that, in a mouse model of ...
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 ...
Modern blepharoplasty focuses on preservation and repositioning of orbital fat, addressing volume loss and ligamentous laxity for natural results. Fat grafting and dermal fillers provide restorative ...
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 ...
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