FDA
Excerpt from the Press Release: NTLA-5001 is Intellia’s first ex vivo candidate using its proprietary cell engineering process for the treatment of cancer to enter clinical study NTLA-5001 targets Wilms’ Tumor 1 (WT1), an overexpressed intracellular antigen on many hematologic malignancies and solid tumors Initiation of patient screening in Phase 1/2a study of NTLA-5001 expected…
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Excerpt from the Press Release: WATERTOWN, Mass., Aug. 11, 2021 (GLOBE NEWSWIRE) — C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company pioneering a new class of small-molecule medicines that selectively destroy disease-causing proteins through degradation, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to CFT7455…
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Excerpt from the Press Release: Moderna Inc. plans to double enrollment in a trial of its Covid vaccine in children under age 12, following a request from U.S. regulators to collect additional safety data. Moderna’s study will enroll an estimated 13,275 participants ages 6 months up to 12 years old, according to a listing on the clinicaltrials.gov website. In a…
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Excerpt from the Press Release: TOLEDO, Ohio & PHILADELPHIA–(BUSINESS WIRE)–NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of Clinlogix, a leading, Philadelphia-based global clinical research organization. Third in an advancing series, this acquisition follows NAMSA’s purchase announcements of Syntactx and American Preclinical Services (APS) in early…
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Excerpt from the Press Release: RADNOR, Pa.–(BUSINESS WIRE)–Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of its lead product candidate ganaxolone, to treat seizures…
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Excerpt from the Press Release: Vaxart (NSDQ:VXRT) announced today that the FDA cleared the investigational new drug (IND) application for its oral COVID-19 vaccine. Upon news of the IND application approval for the S-only protein construct-based vaccine candidate, shares of VXRT were up 16.1% at $8.35 in early-morning trading today. Click the button below to read…
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Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Aug. 2, 2021 /PRNewswire/ — Vaxart, Inc., (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral vaccines administered by tablet, announced today that the U.S. Food and Drug Administration has cleared Vaxart’s Investigational New Drug application for an S-only oral tablet SARS-CoV-2 vaccine candidate. “This is great news because it allows us to move forward…
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Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Magenta Therapeutics, Inc. (Nasdaq: MGTA) today announced that it has received a clinical hold letter from the U.S. Food and Drug Administration (FDA) related to its Investigational New Drug Application (IND) filed in June 2021 to initiate a Phase 1/2 clinical trial of MGTA-117 in patients with acute…
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Excerpt from the Press Release: WATERTOWN, Mass.–(BUSINESS WIRE)–Lyndra Therapeutics, a clinical-stage biotechnology company working to make daily pills a thing of the past, today announced the positive outcome of an end-of-phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) providing a clear path to approval for Lyndra’s Weekly Risperidone (LYN-005), the company’s…
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The FDA has released a new Action Plan on Artificial Intelligence/Machine Learning (AI/ML)- Software as a Medical Device (SaMD). You can download it below by clicking the button! Download The Action Plan
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