Category - Developments

Developments

TGA approves MediWound’s NexoBrid for burn management in Australia

MediWound (NASDAQ: MDWD) has announced that Australia’s Therapeutic Goods Administration (TGA) has granted marketing authorization for NexoBrid—an enzymatic therapy for the removal of eschar in both adult and pediatric...

September 25, 2025

Developments

GeoVax expands with additional solid tumor targets for Gedeptin

GeoVax Labs (NASDAQ: GOVX) has announced the expansion of its oncology development strategy to evaluate additional solid tumor targets for Gedeptin—its gene-directed enzyme prodrug therapy. According to GeoVax, the...

September 24, 2025

Developments

IGC announces pre-clinical data for TGR-63 in AD

IGC Pharma (NYSE: IGC) has announced preclinical findings on its investigational small molecule candidate for Alzheimer’s disease (AD) demonstrating that TGR-63 extends its therapeutic potential beyond previously...

September 24, 2025

Developments

Hemogenyx, Cellin sign LOI to commercialize cell therapy for R/R AML in Estonia

Hemogenyx Pharmaceuticals (LSE: HEMO) has announced the signing of a letter of intent (LOI) with closely held Cellin Technologies to explore the commercialization of its HG-CT-1 CAR-T cell therapy for the treatment of...

September 23, 2025

Developments

EC and Swissmedic approve KalVista’s oral treatment for HAE

KalVista Pharmaceuticals (NASDAQ: KALV) announced that the European Commission (EC) and Swiss Agency for Therapeutic Products (Swissmedic) have approved EKTERLY (sebetralstat), a novel, oral plasma kallikrein inhibitor...

September 19, 2025

Developments

Palisade announces positive PALI-2108 data

Palisade Bio (NASDAQ: PALI) has announced new data from its ongoing clinical program evaluating PALI-2108, a first-in-class, ileocolonic-targeted PDE4 B/D inhibitor. The company plans to present the results in an oral...

September 17, 2025

Developments

Vivos unveils landmark trial results in pediatric OSA treatment

Vivos Therapeutics (NASDAQ: VVOS) has announced first time, peer-reviewed published data confirming that the Vivos Daytime-Nighttime Appliance (DNA) is both safe and efficacious in treating children suffering from...

September 17, 2025

Developments

FDA grants Corbus fast track designation for CRB-701 in HNSCC

Corbus Pharmaceuticals (NASDAQ: CRBP) has announced that the FDA has granted fast track designation to its next-generation Nectin-4 antibody drug conjugate CRB-701 for the treatment of recurrent or metastatic head and...

September 16, 2025

Developments

Adagene, Exelixis amend license agreement to develop third masked mAb

Adagene (NASDAQ: ADAG) has announced an amendment to the 2021 collaboration and license agreement with Exelixis (Nasdaq: EXEL) to enable the development of a third novel masked monoclonal antibody (mAb) drug conjugate...

September 16, 2025

Developments

Actinogen, FDA agree on activities toward marketing approval of Xanamem for AD

Actinogen Medical (ASX: ACW) has announced that an agreement with the FDA has been reached in a scheduled Type C meeting on the manufacturing, clinical, and nonclinical activities required for a future US marketing...

September 16, 2025

Category - Developments

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