UroGen Pharma announced the acceptance of its NDA by the U.S. FDA for the investigational product UGN-102 (mitomycin) intended for intravesical administration.

Adicet Bio has received FDA approval for an IND amendment to study ADI-001 in idiopathic inflammatory myopathy and Stiff Person Syndrome.

ViiV Healthcare reports over 99% effectiveness for Apretude (Cabotegravir Long-Acting) in real-world studies.

Sanofi has partnered with Orano Med, a branch of the Orano Group that leads in the advancement of targeted alpha therapies for cancer treatment.

uniQure N.V. has announced that the initial participant has received a dose in the Phase I/II clinical study of AMT-162.

The application of AI in drug discovery can reduce the development timeline and increase the success rate of new drugs from 12% to 14%.

Three novel drugs by Gan & Lee Pharmaceuticals-GZR18, GZR4, and GZR101 injections-meet primary goals in Phase 2 trials.

Lumasiran works by specifically binding to HAO1 mRNA and promoting its degradation, thereby reducing the synthesis of GO enzyme.

Amgen reveals favorable Phase 3 results for Uplizna® (inebilizumab-cdon) in treating generalized myasthenia gravis at AANEM 2024.

Golodirsen is a phosphorodiamidate morpholino oligomer (PMO), a class of synthetic oligonucleotides designed for high stability and resistance to enzymatic degradation. 

In a Phase 2/3 study, nipocalimab effectively controls symptoms in teenagers with generalized myasthenia gravis.

Beacon Therapeutics Reports Favorable 24-Month Results from Phase 2 SKYLINE Study of AGTC-501 in X-Linked Retinitis Pigmentosa Patients.