FDA
Based upon observed efficacy and safety profile, Praxis intends to engage with the FDA in an end of Phase 2 meeting and initiate a ulixacaltamide Phase 3 study for the treatment of essential tremor in 2H23 Ulixacaltamide demonstrated improvement in modified Activities of Daily Living (mADL) primary efficacy endpoint relative to placebo that did not…
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NTLA-2002 is a single dose, in vivo genome editing candidate designed to prevent potentially life-threatening swelling attacks in people with HAE Excerpt from the Press Release: CAMBRIDGE, Mass., March 02, 2023 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative therapies leveraging CRISPR-based technologies, today announced…
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– Phase 1 trial showed 30% CR rate among 20 NPM1-mutant AML patients treated at recommended Phase 2 dose – – Phase 2 registration-directed trial expected to enroll 85 patients in the U.S. and Europe – Excerpt from the Press Release: SAN DIEGO, Feb. 09, 2023 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (Nasdaq: KURA), a…
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BCMA/CD19 dual-targeting FasTCAR-T GC012F has demonstrated deep responses and favorable safety profile in proof of concept clinical studies Company plans to initiate Phase 1b/2 clinical trial in the U.S. in second quarter of 2023 Excerpt from the Press Release: SAN DIEGO Calif., and SUZHOU and SHANGHAI, China, Feb. 3, 2023 /PRNewswire/ — Gracell Biotechnologies Inc. (“Gracell”…
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Achieves CE Mark for Halcyon and Ethos Radiotherapy Systems Featuring HyperSight Excerpt from the Press Release: PALO ALTO, Calif., Feb. 2, 2023 /PRNewswire/ — Varian, a Siemens Healthineers company, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as CE mark, for Halcyon® and Ethos™ radiotherapy…
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Excerpt from the Press Release: EMERYVILLE, Calif., Feb. 02, 2023 (GLOBE NEWSWIRE) — 4D Molecular Therapeutics (Nasdaq: FDMT, “4DMT”), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, announced FDA clearance of the Investigational New Drug Application (IND) for 4D-150, an R100 vector-based intravitreal genetic medicine, for the treatment of patients…
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TNG908 granted Orphan Drug Designation in U.S. for the treatment of malignant glioma Excerpt from the Press Release: BOSTON, Jan. 25, 2023 (GLOBE NEWSWIRE) — Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, today announced that the U.S. Food and Drug Administration…
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Excerpt from the Press Release: As we begin a new year, a singular message rings true across all pockets of the life science industry – we must ‘do more with less.’ This message was echoed during the recent JP Morgan Healthcare Conference and will continue to resonate throughout the year. The macroeconomic conditions facing our…
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Excerpt from the Press Release: BOSTON, Jan. 26, 2023 (GLOBE NEWSWIRE) — LAPIX Therapeutics, Inc. (“LAPIX”), a biopharma company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases and oncology, today announced the successful outcome of its pre-IND meeting request with the U.S. Food and Drug Administration (FDA). The meeting’s objective…
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LB101 is a conditionally tetravalent PD-L1xCD47 LockBody bispecific monoclonal antibody being developed for solid tumors Excerpt from the Press Release: BOSTON and LONDON, Jan. 26, 2023 (GLOBE NEWSWIRE) — Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today announced that it has received…
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