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News about "US Food and Drug Administration (FDA) "
FDA Lifts Partial Clinical Hold on Vanda's Tradipitant for Motion Sickness
The lift allows Vanda to extend clinical studies of tradipitant in motion sickness. Meanwhile, the review of the fully completed New Drug Application for tradipitant for the prevention of vomiting induced by motion remains on track.
US Food And Drug Administration (FDA) | 05/12/2025 | By Dineshwori
Zaynich milestone: First Indian-developed NCE accepted by US FDA
Wockhardt Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its novel, first-in-class antibiotic Zaynich.
U.S. Food And Drug Administration (FDA) | 02/12/2025 | By Darshana | 109
Ocuvex Resubmits CRL to FDA for PDP-716 NDA, SPARC Reveals
Sun Pharma Advanced Research Company (SPARC) announced that Ocuvex Therapeutics has resubmitted a Complete Response Letter (CRL) to the US Food and Drug Administration (FDA) for the New Drug Application (NDA) of PDP-716.
US Food And Drug Administration (FDA) | 20/11/2025 | By Dineshwori | 122
Ascelia Pharma Strengthens Market Protection for Orviglance with New Patent Filing
Sweden-based biotech company Ascelia Pharma has filed a new patent application for its first-in-class orphan liver imaging drug, Orviglance.
US Food And Drug Administration (FDA) | 10/11/2025 | By Dineshwori
DARZALEX FASPRO is the first and only approved treatment for high-risk smoldering multiple myeloma, according to Johnson & Johnson.
US Food And Drug Administration (FDA) | 07/11/2025 | By Dineshwori | 153
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 | 191
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 | 142
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 | 125
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 | 110
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 | 268
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