FDA
— FDA clearance of the IND, together with the previously cleared CTA, establishes a global Phase 1/2 clinical program for PM577a — — PM577a targets the H1069Q mutation in the ATP7B gene, the most prevalent WD-causing allele in North America and Europe — — Initial clinical data expected in 2027 — Excerpt from the Press…
MAXONA is Developing MAX-001 as a Non-Opioid, Non-NSAID Solid Oral Prescription Therapy for the Treatment of Acute and Chronic Pain and Potential Additional Indications MAX-001 is a Proprietary Optimized Extended Release Form of Nefopam Nefopam is a New Molecular Entity (NME) in the U.S. with a Well Documented Safety and Efficacy Profile in Treating Acute…
Half of planned clinical sites will be activated this month; more than 20 patients have been pre-identified across participating centers Company to hold Type D meeting with FDA to discuss a potential registrational pathway through the addition of Part B to the existing REO 033 trial design Part B will be a randomized study designed…
— ATR 1072 is the company’s first precision cardiology program to enter the clinic — — Corventis™ will be the first clinical trial for people living with PRKAG2 syndrome that evaluates a potential treatment for the underlying cause of the disease — Excerpt from the Press Release: SAN DIEGO, July 14, 2026 /PRNewswire/ — Atrium…
Clearance advances 8M2D, designed to inhibit β-amyloid production rather than clear plaque after it forms; first participant expected to be dosed in late 2026 Excerpt from the Press Release: LA JOLLA, CA / ACCESS Newswire / June 17, 2026 / The U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application…
A randomized, controlled study of a novel liquid embolic, NeoCast, adjunctive to surgery Excerpt from the Press Release: WALTHAM, Mass.–(BUSINESS WIRE)–Arsenal Medical, a clinical-stage company developing innovative biomaterial-based devices, announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for RADIANT, a pivotal trial evaluating NeoCast™. NeoCast is a…
Excerpt from the Press Release: TAIPEI and SAN DIEGO, May 5, 2026 /PRNewswire/ — Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company today announced the initiation of a global, multi-center clinical trial. The Company has also submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), marking a key…
Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., April 30, 2026 /PRNewswire/ — IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company, today announced that the U.S. Food and Drug Administration (FDA) has agreed to review its New Drug Application (NDA) for darovasertib in combination with crizotinib (darovasertib combination) for patients with first…
Phase 1 dose-escalation trial represents the first clinical trial of a product developed using the AraLinQ™ ADC technology and marks Taiho’s expansion into the clinical development of ADCs for oncology Excerpt from the Press Release: PRINCETON, N.J. & TOKYO & ZURICH–(BUSINESS WIRE)–Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Araris Biotech AG (“Araris”) today announced…
Excerpt from the Press Release: NEWTON, Mass.–(BUSINESS WIRE)–Abcuro, Inc., a clinical stage biotechnology company, today presented results at the 6th Global Conference on Myositis (GCOM) meeting, being held March 23-26, 2026 in Lisbon, Portugal from the Phase 2/3 MUSCLE clinical study of ulviprubart (ABC008), an investigational monoclonal antibody in development for the treatment of patients…