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.
XtalPi submits US FDA IND application for KQTD-126 in chronic intestinal pain
AbbVie secures EU approval for RINVOQ in polyarticular juvenile idiopathic arthritis
Altesa BioSciences presents positive vapendavir clinical data at ERS International Congress 2026
Kali Therapeutics' KT501 Investigational New Drug application cleared by US FDA
Teva reports positive Phase 2a data for TEV '408 in celiac disease
AbbVie seeks EMA approval for subcutaneous induction of risankizumab in Crohn's disease
AstraZeneca and Amgen report Tezspire met primary endpoints in Phase III EoE trial
Oxcia receives EMA orphan designation for OXC-201 in idiopathic pulmonary fibrosis
Graviton BioScience reports positive trial results for GV101 in chronic Graft versus Host Disease
Cellenkos' CK0803 granted US FDA Fast Track designation for ALS
European Commission grants orphan designation for Vanda's imsidolimab
CureGene commences dosing in Phase I trial of CG-0416
Genetic Analysis launches microbiome test at Centre for Digestive Diseases in Sydney
Can-Fite reports preclinical data supporting Phase IIb pancreatic cancer study