Tag Archives: NDA

December, 2018

20 December
Sarepta Completes Submission of NDA Seeking Approval of Golodirsen in Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53

CAMBRIDGE, Mass., Dec. 20, 2018 (GLOBE NEWSWIRE) — Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a leader in precision genetic medicine for rare diseases, announced today that it has completed the submission of its rolling New Drug Application (NDA) seeking accelerated approval for golodirsen (SRP-4053), a phosphordiamidate morpholino oligimer engineered to treat those …
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20 December
AbbVie Submits Applications to the FDA and EMA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis

NORTH CHICAGO, Ill., Dec. 20, 2018 /PRNewswire/ — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for upadacitinib, an oral investigational JAK1-selective inhibitor, for …
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26 November
FDA Accepts Biohaven’s NDA for BHV-0223, a Sublingual Delivery Form of Riluzole for Treatment of Amyotrophic Lateral Sclerosis

NEW HAVEN, Conn., Nov. 26, 2018 /PRNewswire/ — Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced that its 505(b)(2) new drug application (NDA) for BHV-0223, an investigational sublingual form of riluzole for the treatment of people living with amyotrophic lateral sclerosis (ALS), has been accepted for review by the U.S. Food and …
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8 October
FDA Accepts Novartis’ NDA for Investigational Siponimod for the Treatment of Secondary Progressive Multiple Sclerosis

Basel, October 08, 2018 – Novartis today announced that both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the company’s New Drug Application (NDA) and Marketing Authorization Application (MAA) respectively, for investigational oral, once-daily siponimod (BAF312) for the treatment of secondary progressive multiple sclerosis (SPMS) in …
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2 August
FDA Approves Progenics’ Azedra for the Treatment of Rare Adrenal Tumors

NEW YORK, July 30, 2018 (GLOBE NEWSWIRE) — Progenics Pharmaceuticals, Inc.(Nasdaq:PGNX) today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for AZEDRA (iobenguane I 131) 555 MBq/mL injection for intravenous use. AZEDRA, a radiotherapeutic, is indicated for the treatment of adult and pediatric patients 12 years and …
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3 November
FDA Accepts Ortho Dermatologics’ NDA for IDP-118 for the Treatment of Plaque Psoriasis

LAVAL, Quebec, Nov. 2, 2017 /PRNewswire/ — Ortho Dermatologics, a division of Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for IDP-118 (halobetasol propionate and tazarotene) lotion, an investigational topical treatment for …
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12 October
FDA Grants Priority Review for Lilly’s Verzenio as Initial Treatment of Advanced Breast Cancer

INDIANAPOLIS, Oct. 12, 2017 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for its New Drug Application (NDA) for Verzenio™(abemaciclib), a cyclin-dependent kinase (CDK)4 & 6 inhibitor. The NDA was based upon the positive interim results from MONARCH 3, a study …
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13 September
FDA to Review Array BioPharma’s NDAs for Binimetinib and Encorafenib for Advanced BRAF-Mutant Melanoma

BOULDER, Colo., Sept. 12, 2017 /PRNewswire/ — Array BioPharma (Nasdaq: ARRY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Applications (NDAs) to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the treatment of patients with BRAF-mutant advanced, …
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5 July
Array Submits NDA to FDA for Binimetinib and Encorafenib in Advanced Melanoma

BOULDER, Colo., July 5, 2017 /PRNewswire/ — Array BioPharma (Nasdaq: ARRY) today announced the submission of two New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) to support use of the combination of binimetinib 45 mg twice daily and encorafenib 450 mg once daily (COMBO450) for the …
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12 June
Gilead Submits Application for Investigational Triple Therapy HIV Treatment to the FDA

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (NASDAQ: GILD) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily single tablet regimen containing bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 …
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