Drug Approval | May 25, 2026
Datroway wins US nod in aggressive breast cancer subtype
Clearance marks major shift beyond chemotherapy
Clearance marks major shift beyond chemotherapy
AstraZeneca highlighted the move as a major step toward earlier intervention in curable disease
The study has shown that perioperative treatment with Imfinzi (durvalumab), alone or in combination with other immunotherapy agents
IgAN is a rare, progressive kidney disease driven by abnormal IgA immune complexes that deposit in the kidneys
The programme features headline data from pivotal Phase III trials, including PREVAIL in gMG, KOMET in NF1-PN, and CHAMPION-NMOSD, alongside real-world evidence supporting established therapies
In just the last few days, companies including Lupin, Biocon, Alembic Pharmaceuticals and Aurobindo Pharma have announced approvals for 5 mg and 10 mg tablets, all bioequivalent to Farxiga
Approval for 5 mg and 10 mg strengths, bioequivalent to Farxiga®, strengthens Lupin’s anti-diabetic portfolio in US market
Immediate U.S. launch planned for Farxiga®-equivalent diabetes drug; opportunity pegged at $10.2 billion in annual market size
Immediate U.S. launch planned for dapagliflozin-metformin ER tablets; addressable market estimated at $514 millionannually
Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.
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