Tag: regulatory strategy

June 9, 2026
Announcement no. 12

PHOENIX, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a clinical-stage biotechnology company focused on regenerative and immune cellular therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its lead investigational therapy, CELZ-201-DDT, for the treatment of degenerative disc disease (DDD), a major cause of chronic lower back pain and disability.

NEWTOWN, Pa., Aug. 08, 2025 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing novel therapies to target critical threats to human health from respiratory viral diseases, today announced plans to host a conference call and webcast on Thursday, August 14, 2025 at 8:30 AM ET to discuss financial results for the second quarter ended June 30, 2025 and recent business progress.

ACTON, Mass., Aug. 07, 2025 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”), a medical diagnostics company developing near-patient solutions for critical care, today announced financial results for the quarter ended June 30, 2025, and provided an update on its Symphony IL-6 test program and key operational milestones.

Abivax Announces Launch of Public Offering

SAN CARLOS, Calif., July 10, 2025 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced the appointment of Marc. R Theoret, M.D. to assume the newly created position of Senior Vice President, Regulatory Strategy, where he will focus on clinical regulatory strategy for Iovance’s pipeline. Effective immediately, Dr. Theoret will report to Dr. Raj K. Puri, M.D., Ph.D., Chief Regulatory Officer.

Daix (France), New York City (New York, United States), July 9, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (“Inventiva” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced a leadership transition with the appointment of Jason Campagna, MD, PhD, as President of Research and Development (“R&D”) and Chief Medical Officer (“CMO”) and Martine Zimmermann, PharmD, as Executive Vice President (“EVP”) of Regulatory Affairs and Quality Assurance.