FDA
Company confirms FDA agreement on key elements of the Phase 3 segment of ongoing RINGSIDE study, including dosing regimen of 1.2mg once daily Enrollment in Phase 3 continuing as planned Excerpt from the Press Release: REHOVOT, Israel & MONMOUTH JUNCTION, N.J., July 05, 2023 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology…
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Excerpt from the Press Release: WATERTOWN, Mass., July 05, 2023 (GLOBE NEWSWIRE) — C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation (TPD) science to develop a new generation of small-molecule medicines and transform how disease is treated, today announced that the U.S. Food and Drug Administration (FDA)…
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Excerpt from the Press Release: The Food and Drug Administration has fully approved the first drug shown to slow down Alzheimer’s disease. The action means that Leqembi, whose generic name is lecanemab, should be widely covered by the federal Medicare health insurance program, which primarily serves adults age 65 and older. So more people who…
Read MoreExcerpt from the Press Release: UTRECHT, The Netherlands and CAMBRIDGE, Mass., June 29, 2023 (GLOBE NEWSWIRE) — Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®) for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for zenocutuzumab (Zeno) for the treatment…
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-Company on track to begin enrolling healthy volunteers in the second half of 2023- Excerpt from the Press Release: DIEGO–(BUSINESS WIRE)–Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, today announced that the U.S. Food and Drug Administration (FDA) cleared the company to initiate its Phase 1 clinical trial of PIPE-791 in healthy volunteers. The…
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Excerpt from the Press Release: PALO ALTO, Calif., May 04, 2023 (GLOBE NEWSWIRE) — Scilex Holding Company (Nasdaq: SCLX, “Scilex”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced complete enrollment in…
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Excerpt from the Press Release: SAN DIEGO and SHANGHAI, May 4, 2023 /PRNewswire/ — ABM Therapeutics, an innovative clinical-stage biopharmaceutical company, with an emphasis on developing drugs with high blood–brain barrier (BBB) penetration for CNS diseases including brain metastases, today announced that the first patient was successfully dosed with ABM-168 in the United States. MEK…
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Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Vega Therapeutics, Inc., a clinical stage biotechnology company developing novel therapies for rare blood disorders, today announced that its clinical trial program for VGA039 has been initiated. The first subject has been dosed in the Phase 1 study of VGA039 (NCT05776069), a multinational clinical trial being…
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Excerpt from the Press Release: CONCORD, Mass., March 30, 2023 /PRNewswire/ — Comanche Biopharma Corp., a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for Comanche’s novel, siRNA therapy to treat preeclampsia. Preeclampsia is a prevalent hypertensive disorder of pregnancy for which there…
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The planned Phase 3 program consists of three trials, SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes to evaluate the safety and efficacy of efruxifermin (EFX) in patients with NASH SYNCHRONY Histology and SYNCHRONY Real-World are expected to begin enrollment in the second half of this year Consistent with the encouraging clinical profile to date reported…
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