NDA
— 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…
— 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…
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…