This trial aims to evaluate the safety and tolerability of MOMA-313, an innovative and highly potent, selective oral inhibitor targeting polymerase theta helicase.

The proposal seeks regulatory approval under the TGA’s Clinical Trial Notification (CTN) scheme to initiate a first-in-human Phase 1 clinical trial for SAT-3247.

This trial is evaluating MRT-6160, an MGD aimed at VAV1, intended for treating systemic and neurological autoimmune conditions.

The EMA has accepted a Type II Variation Application for ENHERTU® to treat patients with HER2 low or ultralow metastatic breast cancer after at least one endocrine therapy.

uniQure N.V. has reported that the inaugural patient has received a dose in a Phase I/IIa clinical trial of AMT-191 targeting Fabry disease.

Imfinzi received Priority Review and Breakthrough Therapy Designation in the US for patients with limited-stage small cell lung cancer.

Turnstone Biologics Corp. Announces Encouraging Early Results from TIDAL-01 Phase 1 Study in Advanced Colorectal Cancer.

Immutep Limited has announced the successful dosing of the initial participant in the first-in-human Phase I trial of IMP761.

Sionna Therapeutics announced that the first participants have been dosed in two Phase 1 trials of SION-719 and SION-451 in healthy volunteers.

Aegle Therapeutics Corp. reveals the initial patient treated in the Phase 1/2a study of AGLE-102™ for Dystrophic Epidermolysis Bullosa.

The U.S. FDA has granted accelerated approval to Gilead's Livdelzi (Seladelpar) for treating primary biliary cholangitis.

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) disclosed preclinical data and outlined its strategy to move two advanced RNAi-based candidates, ARO-INHBE and ARO-ALK7.