Drug Approval | April 21, 2026
Orbicular's partner secures tentative U.S. ANDA approval for a generic version of Ozempic
OneSource is the contract development and manufacturing organization (CDMO) partner for this product
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
This marks a meaningful step in the company's continued expansion in the region
Beyond clinical trials, real-world evidence is adding weight to AbbVie’s claims
TERN-701, a next-generation therapy targeting chronic myeloid leukemia (CML), a form of blood cancer that still presents treatment challenges despite decades of advances
The newly classified assays join Roche’s Ionify 25-Hydroxy Vitamin D total assay in a growing U.S. portfolio
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