Ascletis Pharma Inc. has declared the commencement of a pivotal Phase III clinical study for its fatty acid synthase inhibitor, ASC40 (Denifanstat) , aimed at addressing the therapeutic needs of individuals with moderate to severe acne vulgaris.

Merus N.V. has revealed fresh interim clinical findings on their candidate molecule MCLA-129.

UCB has received the green light from European regulators to market ZILBRYSQ[®] (zilucoplan) as a therapeutic option for generalized Myasthenia Gravis in adult patients.

Sana Biotechnology Releases Initial Clinical Findings Demonstrating SC291, an Off-the-Shelf CAR T Treatment Targeting CD19, Remains Undetected by a Functional Immune System.

Benitec Biopharma has reported initial dosing in an early-stage trial for its genetic treatment prospect, BB-301, aimed at tackling Oculopharyngeal Muscular Dystrophy.

Ambrx Reports Progress on APEX-01 Trial, a Phase 1 / 2 Study Assessing Increasing Doses of ARX517, Its Own PSMA-Directed Antibody-Drug Conjugate, in Advanced Prostate Cancer Unresponsive to Hormonal Therapy.

uniQure N.V., a leader in gene therapy, has announced FDA approval of its IND application for AMT-191 to treat severe medical conditions.

BioVie Inc., a biopharmaceutical firm focusing on neurological, neurodegenerative, and severe liver diseases, reported positive initial results from its Phase 3 trial of NE3107 in mild to moderate Alzheimer’s patients.

Carisma Therapeutics Inc. has confirmed that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for their novel product, CT-0525.

Bio-Thera Solutions has reported encouraging outcomes from its pivotal Phase 3 clinical trial involving BAT2206, a candidate biosimilar for Stelara®.

Halia Therapeutics Reveals Promising Initial Clinical Outcomes for Drug HT-6184 during the Fifth Summit on Inflammasome Treatment Strategies.

OncoResponse, a clinical-stage biotech innovator specializing in immunotherapy derived from elite cancer survivors, announced the first dosing in a Phase 1/2 trial of OR502.