TAIPEI, Aug. 4, 2025 /PRNewswire/ — Anbogen Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for ABT-301, enabling the initiation of a Phase 1/2 […]
Tag: FDA Approval
WuXi Biologics Secures FDA PLI Approval for Five Facilities, First for Commercial PFS Line
WuXi Biologics’ pre-filled syringes (PFS) commercial production line passed its first FDA inspection, paving the way for global delivery of high-quality PFS solutions to clients worldwide Reinforces WuXi Biologics’ strong track record of a 100% success […]
Trailblazing Technology Using Brain Stimulation for Depression and Optimize Mental Health
EXOMIND launch event slated for July 25 SCOTTSDALE, Ariz., July 15, 2025 /PRNewswire/ — For those seeking to lessen their anxiety, treat depression or enhance cognitive functioning without medication, a groundbreaking technology now is available at […]
FDA approves updated label for Lilly’s Kisunla (donanemab-azbt) with new dosing in early symptomatic Alzheimer’s disease
The newly recommended dosing schedule significantly lowered ARIA-E rates compared to the original dosing schedule, adding to the established safety profile of the treatment INDIANAPOLIS, July 9, 2025 /PRNewswire/ — Eli Lilly and Company (NYSE: […]
U.S. FDA Grants Orphan Drug Designation to Adcentrx Therapeutics’ ADRX-0405 STEAP1 ADC for Gastric Cancer
Orphan drug designation highlights the potential for ADRX-0405 to address the high unmet need in gastric cancer SAN DIEGO, July 8, 2025 /PRNewswire/ — Adcentrx Therapeutics (“Adcentrx”), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for […]
