BioSpace News Archive

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.

The Sickle Cell Disease Foundation (SCDF) is proud to announce a research collaboration agreement (RCA) with the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) to develop best practices for the safe and effective use of artificial intelligence (AI) and machine learning (ML) systems and digitally-derived measures that matter to patients.

TELA Bio, Inc. announced that it has appointed Jeffrey Blizard, the Global Head of Surgical Sales for Abiomed, a medical device technology company that operates as a stand-alone business within Johnson & Johnson’s MedTech Segment, to its Board of Directors, effective June 4, 2024.

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultrarare genetic diseases, today announced that Emil Kakkis, M.D., Ph.D., the company’s chief executive officer, will participate in a fireside at the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024, at 10:00 a.m. ET.

Vor Bio announced that, effective as of June 1, 2024, the Compensation Committee of the Board of Directors granted stock options to purchase an aggregate of 1,000 shares of Vor Bio’s common stock and restricted stock units representing the right to receive an aggregate of 1,500 shares of Vor Bio’s common stock to one newly hired employee.

Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) today announced that management will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024 at 8:40 a.m. Eastern Time.

Mural Oncology plc announced that on June 3, the Company granted to two newly hired employees non-statutory stock options to purchase an aggregate of 7,995 ordinary shares of the Company and restricted stock units with respect to an aggregate of 4,305 ordinary shares of the Company, pursuant to the Company’s 2024 Inducement Stock Option and Incentive Plan.

Ocular Therapeutix, Inc. announced that it has agreed to grant inducement awards to its newly appointed Chief Medical Officer, Nadia K. Waheed, MD, MPH, and six other newly hired employees.

Fate Therapeutics, Inc. announced that on June 1, 2024 the Company granted a non-qualified stock option to one newly-hired employee to purchase a total of 65,000 shares of the Company’s common stock at an exercise price per share of $3.68, which was the closing price per share of the Company’s common stock as reported by NASDAQ on May 31, 2024.

Repare Therapeutics Inc. (“Repare” or the “Company”) (Nasdaq: RPTX) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to lunresertib in combination with camonsertib for the treatment of adult patients with CCNE1 amplified, or FBXW7 or PPP2R1A-mutated platinum-resistant ovarian cancer.