NDA
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…
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,…
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…
THE COMPANY EXPECTS TO RELEASE TOPLINE RESULTS FOR SKNJCT-003 PHASE 2 CLINICAL TRIAL BEFORE THE END OF Q1 2026 AND REQUEST END-OF-PHASE 2 (EOP2) WITH THE FOOD AND DRUG ADMINISTRATION (FDA) IN H1 2026 Excerpt from the Press Release: PHILADELPHIA, Dec. 15, 2025 (GLOBE NEWSWIRE) — Medicus Pharma Ltd. (NASDAQ: MDCX) (“Medicus” or the “Company”),…
73% of trial participants (11/15 participants) improved on the Overall Cutaneous Venous Malformations Investigator Global Assessment (Overall cVM-IGA) at Week 12; 67% of trial participants (10/15 participants) rated as “Much Improved” (+2) or “Very Much Improved” (+3) on the Overall cVM-IGA at Week 12 Achieved statistical significance on multiple pre-specified clinician-reported and patient-reported efficacy endpoints,…
Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Alume Biosciences, a late-clinical stage biotechnology company developing nerve-illuminating technology to enhance surgical safety, today announced the publication of first-in-human data from a Phase 1 clinical trial evaluating bevonescein (ALM-488) in head and neck surgeries. The original research article titled, “Intraoperative Nerve-Specific Fluorescence Imaging in Head and Neck…