BioPharma Accord, Inc. reports the U.S. FDA has greenlit their application for a license regarding their proposed biosimilar to STELARA®, named DMB-3115.
KYV-101, a therapeutic agent by Kyverna, has been granted approval by the American FDA for use in a Phase 2 study, KYSA-7, targeting individuals suffering from advanced, treatment-resistant Multiple Sclerosis.
Bayer AG and its independent subsidiary Asklepios BioPharmaceutical, Inc., focused on gene therapy, have completed data collection for the AB-1005 (AAV2-GDNF) Phase Ib trial after 18 months.
Genascence Corporation has launched a Phase 1b clinical study to evaluate the efficacy of their gene treatment, codenamed GNSC-001, targeting knee osteoarthritis.
Alvotech, a global biopharma company specializing in biosimilars, reported positive early results from a key trial of AVT06, its candidate similar to Eylea® (aflibercept).