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News about "US Food and Drug Administration (FDA) "
UCB Wins FDA Approval for KYGEVVI, First-Ever Treatment for Thymidine Kinase 2 Deficiency
UCB, the Brussels-based multinational biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) for KYGEVVI (doxecitine and doxribtimine), marking the first and only approved treatment for thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients whose symptoms began at or before 12 years of age.
US Food And Drug Administration (FDA) | 04/11/2025 | By Dineshwori
Kemwell Biopharma’s drug-product manufacturing facility in Bengaluru has received clearance from the US Food and Drug Administration (FDA) for the commercial manufacturing and testing of injectable products intended for the US market, following the successful completion of a pre-approval inspection (PAI).
US Food And Drug Administration (FDA) | 29/10/2025 | By Dineshwori
Sanofi's Efdoralprin Alfa Meets Key Goals in Phase-II AATD Emphysema Study
Efdoralprin Alfa was previously granted fast track and Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA) for the treatment of AATD Emphysema. It is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority.
US Food And Drug Administration (FDA) | 27/10/2025 | By Dineshwori
FDA Approves Genentech's Gazyva for Treatment of Lupus Nephritis
The US Food and Drug Administration (FDA) has approved Gazyva (obinutuzumab), developed by Genentech, for the treatment of adults with lupus nephritis (LN), also known as lupus-related kidney disease.
US Food And Drug Administration (FDA) | 21/10/2025 | By Dineshwori
FDA Expands Indications for Celltrion's YUFLYMA to Include Pediatric and Adolescent Patients
Celltrion has announced that the US Food and Drug Administration (FDA) has approved expanded indications for YUFLYMA (adalimumab-aaty) and its unbranded version to include the treatment of hidradenitis suppurativa (HS) in adolescent patients aged 12 years and older, and uveitis (UV) in pediatric patients aged 2 years and older.
US Food And Drug Administration (FDA) | 17/10/2025 | By Dineshwori | 213
After India, Innocan Pharma Secures Patent Allowance in Japan for Liposomal CBD Delivery Platform
Israel-based pharmaceutical technology company Innocan Pharma Corporation has announced that its patent for the liposomal delivery platform LPT-CBD has been allowed in Japan and will be officially granted following the completion of administrative process.
US Food And Drug Administration (FDA) | 16/10/2025 | By Dineshwori | 100
US FDA Completes Pre-Approval Inspection at Lupin's Somerset Facility with One Observation
The US Food and Drug Administration (FDA) has completed a pre-approval inspection of Lupin’s manufacturing facility in Somerset, New Jersey, USA, with one observation.
US Food And Drug Administration (FDA) | 11/10/2025 | By Dineshwori | 218
Celltrion Receives US FDA Approval for EYLEA Biosimilar EYDENZELT
Celltrion has received approval from the US Food and Drug Administration (FDA) for EYDENZELT (aflibercept-boav), a biosimilar to EYLEA (aflibercept), for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).
US Food And Drug Administration (FDA) | 11/10/2025 | By Dineshwori | 153
US FDA Classifies Lupin's Pithampur Unit-2 as Official Action Indicated
The US Food and Drug Administration (FDA) has concluded its inspection of Lupin’s Pithampur Unit-2 manufacturing facility, issuing a Form 483 with four observations.
US Food And Drug Administration (FDA) | 04/10/2025 | By Dineshwori | 324
Celltrion Launches Tocilizumab Biosimilar AVTOZMA IV in the US Market
AVTOZMA is Celltrion's fifth immunology biologic and seventh biosimilar approved by the US FDA. It will be available in the same presentations as its reference product, Actemra (tocilizumab).
US Food And Drug Administration (FDA) | 03/10/2025 | By Dineshwori | 192
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