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News about "US Food and Drug Administration (FDA) "
Lupin Gets US FDA Tentative Approval for Pitolisant Tablets
US FDA grants tentative approval to Lupin’s Pitolisant Tablets (4.45 mg, 17.8 mg), bioequivalent to Wakix, for approved indications.
US Food And Drug Administration (FDA) | 25/03/2026 | By News Bureau
US FDA Delays Two Drug Reviews Under New Priority Voucher Program
The U.S. Food and Drug Administration (FDA) has delayed the review of two medicines selected under its recently launched Commissioner’s National Priority Voucher Program, after regulators raised concerns related to safety and clinical effectiveness.
U.S. Food And Drug Administration (FDA) | 16/01/2026 | By Darshana | 364
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 | 410
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 | 553
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 | 381
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 | 197
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 | 335
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 | 340
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 | 399
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 | 435
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