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.

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.

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.