New Drug Applications
U.S. Food and Drug Administration Issues Complete Response Letter for the Glepaglutide New Drug Application for the Treatment of Short Bowel Syndrome
Copenhagen, Denmark, December 19, 2024 – Zealand Pharma A/S (Nasdaq: ZEAL) (“Zealand”) (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced that...-
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Pub Date: Thu, 19 Dec 2024 02:12:06 +0000
Tonix Pharmaceuticals Announces FDA Acceptance of the New Drug Application (NDA) for TNX-102 SL for Fibromyalgia
CHATHAM, N.J., Dec. 17, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), today announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA)...-
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Pub Date: Tue, 17 Dec 2024 01:12:06 +0000
Cytokinetics Announces FDA Acceptance of New Drug Application for Aficamten for the Treatment of Obstructive Hypertrophic Cardiomyopathy
SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food & Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for aficamten, a...-
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Pub Date: Mon, 02 Dec 2024 22:12:47 +0000
Applied Therapeutics Receives Complete Response Letter from U.S. FDA Regarding New Drug Application for Govorestat for Classic Galactosemia
NEW YORK, Nov. 27, 2024 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT), a biopharmaceutical company dedicated to creating transformative treatments for rare disease, today announced that the U.S. Food and Drug Administration (FDA) has...-
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Pub Date: Wed, 27 Nov 2024 02:11:14 +0000
Satsuma Pharmaceuticals and SNBL Receive FDA Acceptance of NDA Resubmission of STS101 for the Acute Treatment of Migraine With or Without Aura
DURHAM, N.C., Nov. 26, 2024 /PRNewswire/ -- Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), are pleased to announce that the U.S. Food and Drug...-
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Pub Date: Tue, 26 Nov 2024 01:11:30 +0000
Soleno Therapeutics Announces FDA Extension of Review Period for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome
REDWOOD CITY, Calif., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced...-
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Pub Date: Tue, 26 Nov 2024 01:11:01 +0000
Arrowhead Pharmaceuticals Submits New Drug Application to U.S. FDA for Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
PASADENA, Calif.–(BUSINESS WIRE)–Nov. 18, 2024– Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that it submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for investigational...-
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Pub Date: Mon, 18 Nov 2024 19:11:13 +0000
Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye Disease
LEXINGTON, Mass.--(BUSINESS WIRE)--Nov. 18, 2024-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmitted New Drug Application (NDA) for topical...-
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Pub Date: Mon, 18 Nov 2024 19:11:09 +0000
Abeona Therapeutics Announces FDA Acceptance of BLA Resubmission of Pz-cel for the Treatment of Recessive Dystrophic Epidermolysis Bullosa
CLEVELAND, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Abeona’s resubmission of its Biologics License Application (BLA) for...-
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Pub Date: Tue, 12 Nov 2024 20:11:35 +0000
Datopotamab Deruxtecan New BLA Submitted for Accelerated Approval in the US for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
12 November 2024 -- AstraZeneca and Daiichi Sankyo have submitted a new Biologics License Application (BLA) for accelerated approval in the US for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or...-
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Pub Date: Tue, 12 Nov 2024 18:11:52 +0000
Unicycive Therapeutics Announces U.S. FDA Acceptance of the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
LOS ALTOS, Calif., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”)...-
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Pub Date: Mon, 11 Nov 2024 03:11:58 +0000
Dizal Submits New Drug Application to the U.S. FDA for Sunvozertinib in Treating Relapsed or Refractory Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
November 8, 2024 – Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced today the submission of a New Drug Application (NDA) to the U.S. Food...-
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Pub Date: Fri, 08 Nov 2024 03:11:20 +0000
Neurotech Provides Update on BLA for NT-501 as a Treatment for Macular Telangiectasia Type 2 (MacTel)
Cumberland, R.I., November 8, 2024 (BUSINESS WIRE) – Neurotech Pharmaceuticals, Inc., an innovator in sustained drug delivery for chronic retinal diseases, today announced that the U.S. Food and Drug Administration (FDA), has extended the...-
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Pub Date: Fri, 08 Nov 2024 01:11:54 +0000
Merus Receives FDA Extension of PDUFA for Zenocutuzumab
UTRECHT, The Netherlands and CAMBRIDGE, Mass., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies...-
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Pub Date: Tue, 05 Nov 2024 01:11:36 +0000
Ionis Announces FDA Acceptance of New Drug Application for Donidalorsen for Prophylactic Treatment of HAE
CARLSBAD, Calif., Nov. 4, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational...-
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Pub Date: Mon, 04 Nov 2024 23:11:42 +0000
Lexicon Announces Outcome of FDA Advisory Committee for Zynquista (sotagliflozin) as an Adjunct to Insulin Therapy for Glycemic Control in Adults with Type 1 Diabetes and Chronic Kidney Disease
THE WOODLANDS, Texas, October 31, 2024 -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced the outcome of the U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) Meeting to review the...-
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Pub Date: Thu, 31 Oct 2024 21:10:39 +0000
Verastem Oncology Completes Rolling NDA Submission to the FDA for Avutometinib Plus Defactinib as a Treatment for Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer
BOSTON--(BUSINESS WIRE)--Oct. 31, 2024-- Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced that the Company has completed its rolling New Drug Application...-
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Pub Date: Thu, 31 Oct 2024 03:10:54 +0000
PTC Therapeutics Announces FDA Acceptance of Translarna NDA Resubmission
WARREN, N.J., Oct. 30, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the New Drug Application (NDA) for Translarna™ (ataluren)...-
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Pub Date: Wed, 30 Oct 2024 05:10:26 +0000
Satsuma Pharmaceuticals and SNBL Resubmits the New Drug Application for STS101 (Dihydroergotamine Nasal Powder) for the Acute Treatment of Migraine With or Without Aura
DURHAM, N.C., Oct. 30, 2024 /PRNewswire/ -- Satsuma Pharmaceuticals, Inc., a late-stage biopharmaceutical company, and its corporate parent, Shin Nippon Biomedical Laboratories, Ltd. (TSE:2395), today announced the resubmission of the new drug...-
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Pub Date: Wed, 30 Oct 2024 03:10:02 +0000
Abeona Therapeutics Completes Pz-cel Biologics License Application Resubmission to U.S. Food and Drug Administration
CLEVELAND, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the Company has resubmitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA or Agency) for prademagene...-
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Pub Date: Tue, 29 Oct 2024 22:10:43 +0000
FDA Accepts New Drug Application and Grants Priority Review for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent
Melbourne (Australia) | 24 October 2024 -- Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for TLX101-CDx (Pixclara®[1]), an agent for the imaging of glioma. The...-
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Pub Date: Thu, 24 Oct 2024 03:10:06 +0000
Camurus Provides Regulatory Update on the US NDA for CAM2029 in Acromegaly
Lund, Sweden — 22 October 2024 — Camurus (NASDAQ STO: CAMX) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the new drug application (NDA) for CAM2029 (octreotide)...-
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Pub Date: Tue, 22 Oct 2024 20:10:27 +0000
Elevar Therapeutics Announces FDA Acceptance of New Drug Application Resubmission for Rivoceranib in Combination with Camrelizumab as a First-line Systemic Treatment for Unresectable Hepatocellular Carcinoma
FORT LEE, NEW JERSEY, Oct. 21, 2024 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., today announced the U.S. Food and Drug Administration (FDA) accepted the resubmission of a new drug application (NDA) for its...-
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Pub Date: Mon, 21 Oct 2024 05:10:06 +0000
LENZ Therapeutics Announces FDA Acceptance of New Drug Application for LNZ100 for the Treatment of Presbyopia
SAN DIEGO, Oct. 21, 2024 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a pre-commercial biopharmaceutical company focused on the development and commercialization of the first and only...-
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Pub Date: Mon, 21 Oct 2024 05:10:04 +0000
Tonix Pharmaceuticals Announces Submission of the TNX-102 SL New Drug Application (NDA) for Fibromyalgia to the U.S. Food and Drug Administration (FDA)
CHATHAM, N.J., Oct. 16, 2024 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TNX-102 SL...-
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Pub Date: Wed, 16 Oct 2024 04:10:40 +0000