FDA
– Multicenter Phase 1 study to evaluate IO-202 as monotherapy and in combination with an anti-PD-1 Excerpt from the Press Release: PALO ALTO, Calif.–(BUSINESS WIRE)–Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational…
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Excerpt from the Press Release: BEDMINSTER, N.J., Jan. 6, 2022 /PRNewswire/ — Jubilant Therapeutics Inc, a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced U.S. Food and Drug Administration (FDA) clearance of the investigational new drug application (IND) for JBI-802, a novel, oral, potent and selective dual…
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Excerpt from the Press Release: SAN DIEGO, Jan. 20, 2022 (GLOBE NEWSWIRE) — Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced that the company has received clearance from the FDA for the company’s Investigational New Drug (IND) application for the combination of…
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Excerpt from the Press Release: TAIPEI and SAN DIEGO, Jan. 20, 2022 /PRNewswire/ — Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for Silmitasertib, a highly selective inhibitor of…
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–FDA States Pivotal Clinical Trial May Proceed, Trial Expected to Commence By March 2022– Excerpt from the Press Release: PHILADELPHIA, Jan. 21, 2022 /PRNewswire/ — Lannett Company, Inc. (NYSE: LCI) today announced that the U.S. Food and Drug Administration (FDA) has notified the company that they have completed the safety review of the Investigational New…
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– FDA lifts partial clinical hold following agreement on mitigation strategy for differentiation syndrome – – KOMET-001 study to resume screening and enrollment of new patients – – Encouraging safety, tolerability and clinical activity observed among patients on study – Excerpt from the Press Release: SAN DIEGO, Jan. 20, 2022 (GLOBE NEWSWIRE) — Kura Oncology,…
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The new company is focused on developing GP-2250, a novel cancer therapeutic with a unique mechanism of action Excerpt from the Press Release: Panavance Therapeutics Inc. (“Panavance”) is a new clinical-stage pharmaceutical company created to advance and develop GP-2250, a patented, novel therapeutic for the treatment of cancer and other therapeutic indications. GP-2250 is a…
Read More Clinical study found that cudetaxestat, a non-competitive inhibitor of autotaxin, was well tolerated and showed no reports of drug-related serious adverse events or discontinuations when co-administered with either pirfenidone or nintedanib Submission of study data to U.S. Food and Drug Administration (FDA) anticipated in first quarter of 2022 Blade expects to advance cudetaxestat into phase…
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Portfolio includes five investigational gene therapy programs for glycogen storage disorders that have no existing FDA-approved treatments available Warden Bio Co-Founder Kunal Kishnani joins as President of Kriya’s Rare Disease Division and will lead its overall strategic, development, and partnership activities Excerpt from the Press Release: REDWOOD CITY, Calif. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–Kriya…
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Excerpt from the Press Release: CAMBRIDGE, Mass. and ROTTERDAM, Netherlands and SUZHOU, China, Jan. 4, 2022 /PRNewswire/ — Harbour BioMed (“HBM”, HKEX: 02142) announced that, its next generation anti-CTLA-4 fully human heavy-chain only antibody (HCAb), HBM4003, has completed the first dosing of first patient in two phase I trials for the treatment of advanced hepatocellular…
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