SILVER SPRING, Md., Dec. 13, 2024 /PRNewswire/ — Today, the U.S. Food and Drug Administration approved Crenessity (crinecerfont) to be used together with glucocorticoids (steroids) to control androgen (a testosterone-like hormone) levels in adults and pediatric […]
Tag: FDA Approval
Diamyd Medical Aligns with FDA on Key Elements for an Accelerated Approval Process
STOCKHOLM, Dec. 13, 2024 /PRNewswire/ — Diamyd Medical today announced a positive in-person Type C meeting with the U.S. Food and Drug Administration (FDA), where alignment was achieved on key components of the planned early […]
Accropeutics Inc. Announces U.S. FDA Clearance of IND Application for RIPK2 Inhibitor AC-101
Company to conduct a Phase II multi-regional clinical trial (MRCT) for the treatment of Ulcerative Colitis (UC) A Phase Ib Study of AC-101 for Ulcerative Colitis (UC) has been initiated in China AC-101 demonstrated a […]
Jazz Pharmaceuticals Announces U.S. FDA Approval of Ziihera® (zanidatamab-hrii) for the Treatment of Adults with Previously Treated, Unresectable or Metastatic HER2-positive (IHC 3+) Biliary Tract Cancer (BTC)
Ziihera is the first and only dual HER2-targeted bispecific antibody approved for HER2+ BTC in the U.S. Ziihera received accelerated approval based on results including a 52% objective response rate and median duration of response […]
RiboX Therapeutics Announces FDA Clearance for IND Application of RXRG001, the First Circular RNA Therapy for the Treatment of Radiation-Induced Xerostomia and Hyposalivation
PRINCETON, N.J., Oct. 25, 2024 /PRNewswire/ — RiboX Therapeutics Ltd. (RiboX), a pioneering biopharmaceutical company, focused on discovering and developing fully engineered circular RNA therapeutics, announced that the US Food and Drug Administration (FDA) has cleared […]









