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

Incyte and Syndax Pharmaceuticals announced that Niktimvo™ (axatilimab-csfr), an anti-CSF-1R antibody, has been approved by the U.S. Food and Drug Administration (FDA).

TransCode Therapeutics has reported the start of its multicenter, open-label, Phase 1 clinical trial for its primary therapeutic candidate, TTX-MC138.

Alvotech declared that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s planned biosimilar to Eylea® (aflibercept).

CV6 Therapeutics has reported the successful administration of the second patient in its Phase 1a clinical trial assessing CV6-168 in combination with infusional 5-fluorouracil (5-FU) for cancer treatment.

Aug 15th latest updates in the global new drug development field, including progress in new drug research and development, transaction information, and partnership developments.

UroGen Submits NDA for UGN-102, Aiming for FDA Approval as the First Treatment for Intermediate-Risk, Low-Grade Non-Muscle Invasive Bladder Cancer.

Verrica Pharmaceuticals Reveals Encouraging Initial Topline Data from Phase 2 Study Part 2 of VP-315, an Experimental Oncolytic Peptide Immunotherapy for Basal Cell Carcinoma Treatment.

ACELYRIN revealed that the Phase 3 trial of izokibep for Hidradenitis Suppurativa (HS) successfully met its primary endpoint of HiSCR75 at the 12-week mark.

Bavarian Nordic A/S (OMX: BAVA) announced today that the U.S. FDA has accepted and given Priority Review status to the Biologics License Application (BLA) for CHIKV VLP(PXVX-0317).

Galderma has revealed that the U.S. FDA has given the green light to Nemluvio® (nemolizumab) as a pre-filled pen designed for subcutaneous injection to treat adults suffering from prurigo nodularis.1.

Biosyngen is excited to share that the U.S. Food and Drug Administration (FDA) has given the green light for its BRG01, an EBV-specific CAR-T cell therapy.