Elanco scores USDA nod for new canine allergy drug Befrena
Elanco expects Befrena to launch in the US in the first half of 2026
Elanco expects Befrena to launch in the US in the first half of 2026
Orphan drug designation (ODD) by the USFDA for Desidustat, provides eligibility for a potential seven-year marketing exclusivity subject to the USFDA approval
Revenue from operations rose 14.8 per cent year-on-year to Rs. 3,942 crore
During Q1FY26, the company incurred Capex of ~Rs. 48.5 crores mainly towards capacity expansion, backward integration and finished formulation R&D
Apotex will also pay US$ 2.5 million upon receipt of final USFDA approval of the ANDA that is the subject of the Collaboration Agreement for Paclitaxel Protein-Bound Particles for Injectable Suspension
UFlex is the first and only Indian company to receive USFDA approval for its technology and capacity to recycle all three materials
Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months
Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
Subscribe To Our Newsletter & Stay Updated