Tag: FDA
Henlius, Organon Secure FDA Approval for PERJETA Biosimilar
Shanghai Henlius Biotech and Organon Announced that the US Food and Drug Administration (FDA) has granted approval to the Biologics License Application for POHERDY®...
FDA Announces Removal of Black Box Warnings on HRT Products
The U.S. Department of Health and Human Services (HHS) announced a major policy shift today aimed at re-establishing what it described as gold-standard scientific...
FDA Grants Approval for CAPLYTA for MDD Treatment in Adults
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted approval for CAPLYTA (lumateperone) to be used as an adjunctive...
FDA Approves J&J’s DARZALEX FASPRO for HR-SMM in Adults
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
UCB, a leading global biopharmaceutical company, has announced that KYGEVVI has received FDA approval for the treatment of adults and pediatric patients diagnosed with...
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