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ACHEMA MIDDLE EAST 2026
5th LNP Formulation & Process Development Summit

Tag: FDA

FDA Approves J&J’s DARZALEX FASPRO for HR-SMM in Adults

Americas
Johnson & Johnson said the U.S. Food and Drug Administration (FDA) has cleared DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for use as a single-agent treatment...

FDA Approves UCB’s KYGEVVI for Thymidine Kinase 2 Deficiency

Americas
UCB, a leading global biopharmaceutical company, has announced that KYGEVVI has received FDA approval for the treatment of adults and pediatric patients diagnosed with...

FDA Unveils Initiative for Faster Biosimilar Development

Americas
The U.S. Food and Drug Administration (FDA) has unveiled a major initiative aimed at cutting both the time and cost required to develop biosimilar...

FDA Approves Omvoh by Eli Lilly for Ulcerative Colitis

Americas
Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has approved a new single-injection, once-monthly maintenance option (200 mg/2...

FDA Approves Novo Nordisk’s Rybelsus Oral GLP-1 Therapy

Americas
Novo Nordisk has announced that the US Food and Drug Administration (FDA) has granted approval for Rybelsus®, the only oral GLP-1 therapy, to reduce...
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