BioSpace News Archive

Retractable Technologies, Inc. reports the following information relating to the year ended December 31, 2022.

SeaStar Medical Holding Corporation, a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, provides a business update and reports financial results for the year ended December 31, 2022.

HUTCHMED Limited announces that it completed the rolling submission of a New Drug Application to the U.S. Food and Drug Administration for fruquintinib, its highly selective and potent oral inhibitor of VEGFR-1, -2 and -3, for the treatment of refractory metastatic colorectal cancer.

Ocuphire Pharma, Inc. (Nasdaq: OCUP) today announced financial results for the fourth quarter and year ended December 31, 2022 and provided a corporate update.

Combined Therapeutics Inc. (CTx) today announced its participation in the upcoming World Vaccine Congress 2023, taking place in Washington, D.C., April 4-6, where it will present its cutting-edge mRNA-based vaccine technology MOPCTx in a poster presentation and oral communication.

RoslinCT and Lykan Bioscience, leaders in ground-breaking Contract Development and Manufacturing for cell therapies, are delighted to announce that following a successful inspection at their Edinburgh, UK facility, from the Medicines and Healthcare products Regulatory Agency (MHRA), a Manufacturer’s Authorisation Licence (MIA) for commercial manufacturing of cell therapy products has been granted.

Akebia Therapeutics®, Inc. (Nasdaq: AKBA) today announced that the company met with the U.S. Food and Drug Administration (FDA) Office of New Drugs (OND) deciding authority to discuss Akebia’s Formal Dispute Resolution regarding the Complete Response Letter for vadadustat received in March 2022.

RenovoRx, Inc. (“RenovoRx” or the “Company”) (Nasdaq: RNXT), a biopharmaceutical company focused on the localized treatment of solid tumors, announced that it will present detailed, open label, planned Phase III interim data analysis of its innovative RenovoGem therapy for pancreatic cancer patients at the American Association for Cancer Research (AACR) Annual Meeting on April 17, 2023 in Orlando, Florida.

Stryker (NYSE:SYK), one of the world’s leading medical technology companies, today announced that Armodios M. Hatzidakis, MD, FAAOS, Western Orthopaedics, PC, Denver Surgery Center and Rose Medical Center, has successfully completed the first case in the United States, since the De Novo clearance, using the Tornier Pyrocarbon Humeral Head.

Vistagen (Nasdaq: VTGN) today announced positive feedback from its recent engagement with the U.S. Food and Drug Administration (FDA) regarding the use of the Liebowitz Social Anxiety Scale (LSAS) as the primary endpoint for future clinical studies designed to evaluate the efficacy of a treatment for the overall control of symptoms of social anxiety disorder (SAD).