The company receives approval for blood-based test enabling objective differentiation of schizophrenia and bipolar disorder
The lens received U.S. Food and Drug Administration (FDA) market authorization via the De Novo pathway in late 2025
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The company plans a phased expansion across India, focusing initially on metro cities and early-adoption hubs
Aims to boost speed & precision in patient care
OneSource is the contract development and manufacturing organization (CDMO) partner for this product
The company stated that it will work closely with the regulator to address the observations within the stipulated timeframe
Panacea Biotec receives LoA from CMSS
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
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