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...

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)...

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...

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...

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...

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...

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...

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...

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...

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...

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”)...

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...

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...

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...

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...

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...

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...

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)...

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...

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...

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...

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)...

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...

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...

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...