Vivani Medical Reports FDA Approval of New Drug Application and Removal of Clinical Hold for NPM-119, a Mini Subdermal GLP-1 Implant.

The FDA has approved Kevzara® (sarilumab) for treating active polyarticular juvenile idiopathic arthritis (pJIA).

Ipsen's Iqirvo® gets expedited U.S. FDA approval as an innovative PPAR therapy for primary biliary cholangitis.

NMD Pharma A/S announced today that it has administered the first dose to a patient with generalized myasthenia gravis in a Phase 2b clinical trial of NMD670.

Alvotech and STADA are expanding their joint efforts to include AVT03, a biosimilar candidate in clinical development that uses Prolia/Xgeva (denosumab) as reference drugs aimed at treating osteoporosis and cancer-induced bone deterioration.

Assembly Biosciences, has reported that the initial participant has received a dose in the Phase 1a/b clinical trial of its long-acting herpes simplex virus helicase-primase inhibitor, ABI-5366.

Entos Pharmaceuticals have announced that Entos has secured authorization from Health Canada to commence a phase 1/2 clinical study assessing Covigenix VAX-002.

The European Commission has authorized Roche's Alecensa as the inaugural and exclusive targeted adjuvant therapy for patients with early-stage ALK-positive lung cancer.

The FDA has approved Almirall’s Klisyri® (tirbanibulin) for treating actinic keratosis on facial or scalp areas up to 100 cm².

Lilly's tirzepatide outperformed placebo in resolving MASH, and over 50% of patients showed fibrosis improvement after 52 weeks.

EASL Conclusion Session Emphasized Novel Clinical Data on Unique HBV-targeted TCR T Cell Therapy (SCG101) Demonstrating Enhanced Survival Rates in HBV-linked Liver Cancer.

Geron Receives FDA Approval for RYTELO™ (imetelstat), a Novel Telomerase Inhibitor, to Treat Transfusion-Dependent Anemia in Adults with Lower-Risk MDS.