FDA
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…
TIGeR-PaC Trial Enrollment Remains on Track for Completion in First Half of 2026, with Final Data Expected in 2027 Select TIGeR-PaC Cancer Centers Now Using RenovoCath® as a Stand-Alone Device for Drug-Delivery in Oncology Management Excerpt from the Press Release: MOUNTAIN VIEW, Calif., March 26, 2026 (GLOBE NEWSWIRE) — RenovoRx, Inc. (“RenovoRx” or “the Company”)…
Excerpt from the Press Release: PRINCETON, N.J., Feb. 20, 2026 /PRNewswire/ — Guerbet, a global specialist in contrast media and solutions for medical imaging, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved a labeling update for Elucirem™ (gadopiclenol) injection. The new indication includes approval for pediatric patients aged 0-2 years…
DARE-HPV development supported by $10 million ARPA-H contract; program targets major unmet need with no FDA-approved therapies Excerpt from the Press Release: SAN DIEGO, Feb. 23, 2026 (GLOBE NEWSWIRE) — Daré Bioscience, Inc. (NASDAQ: DARE), a purpose-driven health biotech company solely focused on closing the gap in women’s health between promising science and real-world solutions,…
AFTX-201 uses Affinia’s proprietary capsid engineered for efficient cardiac transduction at doses that are 5-10-fold lower than doses of gene therapies using conventional capsids Company on track to initiate the UPBEAT© clinical trial to investigate safety, pharmacodynamics, and preliminary efficacy of AFTX-201 in BAG3 DCM in the first half of 2026 Excerpt from the Press Release:…
Patent Enhances IP Estate for Lead Asset; Combined with Anticipated Biologics Exclusivity, Market Protections Extend Over 20 Years Excerpt from the Press Release: PRINCETON, N.J., Jan. 22, 2026 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills…