FDA approves expanded pediatric indications for YUFLYMA® (adalimumab-aaty) and unbranded adalimumab-aaty in the United States
YUFLYMA® (adalimumab-aaty), and its unbranded version, are now approved for two additional pediatric indications – adolescent hidradenitis suppurativa (HS) and pediatric uveitis (UV), in the U.S. [1] , [2] Pediatric UV is a rare eye inflammation in...
FDA Approves New Prostate Cancer Imaging Agent Gozellix®
MELBOURNE, Australia and INDIANAPOLIS, March 21, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New...
Thailand Approves Sunwoda to Invest More Than US$1 billion in EV Battery Cell Plants
BANGKOK, March 13, 2025 /PRNewswire/ -- Thailand's Commission on the National Competitiveness Enhancement for Targeted Industries, at a meeting today, approved an investment by a unit of China's Sunwoda Electronic worth more than a billion dollars...
U.S. FDA approves Celltrion's OMLYCLO® (omalizumab-igec) as the first and only biosimilar with interchangeability designation referencing XOLAIR®
O MLYCLO ® (omalizumab-igec) is the first and only omalizumab biosimilar approved by the FDA Regulatory approval for interchangeability was supported by positive phase III data demonstrating comparable efficacy and safety profile with the reference...
U.S. FDA approves Celltrion's STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab)
STEQEYMA (CT-P43) is approved for both adult and pediatric patients with plaque psoriasis (PsO) and active psoriatic arthritis (PsA) as well as adults with Crohn's disease (CD) and ulcerative colitis (UC) STEQEYMA is a strategic addition to...