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16 Bit Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted a De Novo marketing authorization for Rho™, an AI-enabled software device aimed at improving a known care gap in osteoporosis screening.

Tonix Pharmaceuticals Holding Corp. today announced that it has engaged Rho, Inc. (Rho), a global contract research organization (CRO), to support Tonix’s preparation and planned submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the approval of Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia.

Ocugen, Inc. today announced that the FDA has granted RMAT designation to Ocugen’s investigational product OCU400 for the treatment of retinitis pigmentosa (RP) associated with RHO mutations.

Neurelis, Inc., announced the first two cohorts dosed in the investigational clinical trial of NRL-1049, a Rho kinase (ROCK) inhibitor, a potential treatment for people living with cerebral cavernous malformations (CCM), a disease characterized by abnormally enlarged capillary cavities in the brain and spinal cord.

First Wave BioPharma, Inc. (NASDAQ:FWBI) (“First Wave BioPharma” or the “Company”) announced today that it has entered into an agreement with Rho, a full-service contract research organization (CRO), for its planned Phase 2 clinical trial of an enhanced enteric microgranule delivery formulation for adrulipase.

Neurelis, Inc., announced the successful filing of its investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NRL-1049, a Rho kinase (ROCK) inhibitor with a potential treatment for people living with cerebral cavernous malformations (CCM), a disease characterized by abnormally enlarged capillary cavities in the brain and spinal cord.

argenx SE announced its plan to continue the development of efgartigimod to Phase 3 in adults with primary Sjogren’s disease, following the analysis of topline data from the Phase 2 RHO study.

Rho, a full-service contract research organization with a proven track record of drug development success, announced the appointment of J. Marc Pipas, MD, a leading oncologist, as Senior Medical Director.

Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN) today announced that the Company received alignment from FDA on key aspects of the Phase 3 clinical trial design to assess the safety and efficacy of OCU400 in patients with RHO and other gene mutations associated with Retinitis Pigmentosa (RP).

Ocugen, Inc. announced that the first patient has been dosed in its Phase 3 liMeliGhT clinical trial for OCU400—a modifier gene therapy product candidate being developed for retinitis pigmentosa.