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Results For "USFDA-approval"

194 News Found

Elanco scores USDA nod for new canine allergy drug Befrena
News | January 04, 2026

Elanco scores USDA nod for new canine allergy drug Befrena

Elanco expects Befrena to launch in the US in the first half of 2026


Zydus receives FDA’s ODD for Desidustat for the treatment of beta-thalassemia
Drug Approval | November 06, 2025

Zydus receives FDA’s ODD for Desidustat for the treatment of beta-thalassemia

Orphan drug designation (ODD) by the USFDA for Desidustat, provides eligibility for a potential seven-year marketing exclusivity subject to the USFDA approval


Biocon Q1 FY26 PAT slips 95% to Rs. 31.4 Cr
News | August 08, 2025

Biocon Q1 FY26 PAT slips 95% to Rs. 31.4 Cr

Revenue from operations rose 14.8 per cent year-on-year to Rs. 3,942 crore


Aarti Drugs posts Q1 FY26 PAT higher at Rs. 54 Cr
News | July 21, 2025

Aarti Drugs posts Q1 FY26 PAT higher at Rs. 54 Cr

During Q1FY26, the company incurred Capex of ~Rs. 48.5 crores mainly towards capacity expansion, backward integration and finished formulation R&D


Panacea Biotec reaches settlement with Apotex
News | July 12, 2025

Panacea Biotec reaches settlement with Apotex

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 introduces FSSAI compliant single-pellet solution for food packaging
Packaging | June 20, 2025

UFlex introduces FSSAI compliant single-pellet solution for food packaging

UFlex is the first and only Indian company to receive USFDA approval for its technology and capacity to recycle all three materials


FDA approves Merck’s enflonsia for prevention of RSV in infants
Drug Approval | June 12, 2025

FDA approves Merck’s enflonsia for prevention of RSV in infants

Enflosina is a long-acting monoclonal antibody that provides direct protection for up to 5 months


Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules
Drug Approval | January 31, 2025

Granules strengthens ADHD portfolio with FDA approval for Lisdexamfetamine Dimesylate capsules

Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder in adults and pediatric patients aged six years and older


USFDA inspection of Shilpa Medicare Unit VI at Bengaluru
Drug Approval | November 02, 2024

USFDA inspection of Shilpa Medicare Unit VI at Bengaluru

The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature