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.

NewBridge will have exclusive distribution rights in Algeria, Iraq, Libya, and Jordan for CRYSVITA® (burosumab) for the treatment of X-linked hypophosphatemia (XLH) and tumor-induced osteomalacia (TIO).

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

Recently, Merus announced that the first patient has been dosed in the phase 3 clinical trial LiGeR-HN2.

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

Aug 20th latest updates in the global new drug development field, including progress in new drug research and development, transaction information, and partnership developments.

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.