FDA
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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Excerpt from the Press Release: PRINCETON, N.J., January 18, 2023 – Taiho Oncology, Inc. today announced the publication of results from the pivotal Phase 2 FOENIX*-CCA2 clinical trial of futibatinib in the January 19, 2023 issue of The New England Journal of Medicine (NEJM). The article, “Futibatinib for Intrahepatic Cholangiocarcinoma with FGFR2 Fusions/Rearrangements,” reports on…
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IND demonstrates Mirati’s leadership in KRAS, representing the Company’s third KRAS or KRAS-signaling program to enter clinical development Excerpt from the Press Release: SAN DIEGO, Jan. 19, 2023 /PRNewswire/ — Mirati Therapeutics, Inc. (NASDAQ: MRTX), announced today the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of MRTX1133, a potential…
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Excerpt from the Press Release: CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, Jan. 12, 2023 /PRNewswire/ — Harbour BioMed (the”Company”, HKEX: 02142) announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to commence clinical trials of its globally first-in-class fully human monoclonal antibody HBM1020 targeting B7H7 (also known…
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Excerpt from the Press Release: OAKLAND, Calif., Jan. 4, 2023 /PRNewswire/ — Tempero Bio, Inc, a clinical-stage biopharmaceutical company focused on developing transformative therapies for the treatment and prevention of alcohol and other substance use disorders, today announced the U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for TMP-301.…
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– Spin-off of technology platform to newly-formed Kimia Therapeutics intended to maximize the full potential of Carmot’s metabolic portfolio while enabling Kimia to pursue a broad range of opportunities across oncology, immunology and inflammation – – Encouraging clinical data from CT-388 and CT-868, Carmot’s dual GLP-1/GIP receptor modulators, represent significant opportunity for Carmot to advance…
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Excerpt from the Press Release: FREMONT, CA, Jan. 05, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – ABVC BioPharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology today announced that the US Food & Drug Administration notified the company that the IND application for the proposed clinical investigation…
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Global registrational trial expected to commence in the second half of 2023 Excerpt from the Press Release: BOSTON and LONDON, Jan. 05, 2023 (GLOBE NEWSWIRE) — Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for OTL-203, a…
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Excerpt from the Press Release: BOSTON, Dec. 29, 2022 (GLOBE NEWSWIRE) — TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA Oncology Company™ committed to more effectively treating cancer using RNA therapeutics, announced today that it has received written authorization from the U.S. Food and Drug Administration (FDA) that it may proceed with its First-in-Human (FIH) Phase…
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