Drug Approval | April 08, 2026
Aurobindo Pharma wins USFDA approval for generic Xigduo XR
Immediate U.S. launch planned for dapagliflozin-metformin ER tablets; addressable market estimated at $514 millionannually
Immediate U.S. launch planned for dapagliflozin-metformin ER tablets; addressable market estimated at $514 millionannually
Immediate U.S. launch planned for Farxiga®-equivalent diabetes drug; opportunity pegged at $10.2 billion in annual market size
Immediate opportunity in the $10.2 billion U.S. market as the diabetes therapy will be manufactured at Zydus’ SEZ Ahmedabad facility
Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.
This follows a $6 million expansion in Rosenberg in 2025 and signals a major push to boost commercial capacity, expand R&D capabilities, and meet rising demand for US-based drug product manufacturing
Desidustat tablets are a novel oral HIF-PHI approved for treating anaemia in non-dialysis adult CKD patients
The approval comes after a systematic review of published literature
Pivya is Alembic’s first branded pharmaceutica product in the US and is being marketed through Alembic Therapeutics LLC
Zongertinib is setting a new standard as the first targeted therapy for treatment naïve patients with HER2-mutant advanced non-small cell lung cancer with demonstrated efficacy
The company said the move applies to all doses and reflects its commitment to making its medicines more affordable for patients
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