The U.S. FDA has removed the partial clinical hold previously imposed on MediLink Therapeutics' (Suzhou) Co., Ltd. Phase I trial, which is assessing BNT326/YL202 (NCT05653752) and was disclosed on June 17, 2024.

Apogee Therapeutics Starts Phase 1 Trial for APG990, a New Long-Lasting OX40L Antibody for Atopic Dermatitis and Inflammatory Diseases, with Initial Participants Dosed.

ImmuneSensor Therapeutics Gains Approval from Australian Authorities to Begin First-in-Human Phase 1 Trial for cGAS Inhibitor Drug IMSB301.

GlycoNex has declared the successful conclusion of a Phase 1 clinical trial for its denosumab biosimilar, SPD8.

The European Medicines Agency has accepted Bristol Myers Squibb's application for CAR T cell therapy Breyanzi for treating relapsed or refractory follicular lymphoma.

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.