Bausch Health Companies Inc (NYSE/TSX: BHC), a Canada-based multinational specialty pharmaceutical company, announced on Wednesday that it has received an additional new indication for DEXAVEN (dexamethasone phosphate) solution for injection, 4mg/ml, from the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Poland.
The product is intended to treat COVID-19 in adult and adolescent patients over 12 years of age and older, weighing around 40kg and in need of oxygen therapy. It is a corticosteroid that decreases inflammation.
The United States Food and Drug Administration (FDA) has not granted approval to Dexamethasone-containing products in the United States for the treatment for COVID-19. The products are only to be used in accordance with their approved label and under the directions of the patient's doctor.
Coya Therapeutics wins FDA clearance to advance COYA 302 into Phase 2 ALS trial
Lighthouse Pharmaceuticals announces receipt of USD49.2m grant from NIA for LHP588 study
Bio-Thera and STADA expand biosimilars partnership to include tocilizumab
Shilpa Medicare secures approval for NAFLD therapy NorUDCA in India
Remegen's Telitacicept meets Sjogren's syndrome Phase III trial's primary endpoint
PainReform acquires majority stake in LayerBio to advance dropless cataract surgery therapy
Seragon launches Enlivien sleep and longevity optimiser
Insmed's BRINSUPRI (brensocatib) non-cystic fibrosis bronchiectasis treatment approved by US FDA
Fosun Pharma agrees XH-S004 overseas licensing deal
Novartis reports positive Phase III results for ianalumab in Sjögren's disease