Biocon Biologics signs US settlement with Regeneron to Launch Yesafili Biosimilar by 2026
Settlement agreement allows Biocon Biologics to commercialise interchangeable aflibercept biosimilar Yesafili in the US; launch…
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U.S. Food and Drug Administration (FDA)
Biocon Biologics secures US FDA approval for Biosimilar Bevacizumab, JOBEVNE
The approval marks Biocon Biologics’ seventh biosimilar clearance in the US, expanding its oncology portfolio in one of the…
Shilpa Pharma Lifesciences’ Raichur API facility clears second consecutive FDA inspection with no…
Shilpa Medicare's Unit-2 API facility in Raichur, India passes March 2025 FDA audit without Form 483 observations, reinforcing…
Granules India acquires Senn Chemicals AG to expand peptide therapeutics and CDMO capabilities
Acquisition strengthens Granules’ entry into the peptide-based therapeutics market and enhances CDMO capabilities through Senn’s…
Lupin receives tentative FDA approval for generic Darunavir combination tablets
It will be manufactured at Lupin’s Nagpur facility in India
FDA accepts Eisai’s BLA for LEQEMBI subcutaneous autoinjector for alzheimer’s disease treatment
LEQEMBI’s subcutaneous formulation could simplify maintenance therapy for Alzheimer’s patients, offering a 15-second at-home…
Glenmark launches Lacosamide Oral Solution, bioequivalent to Vimpat
Lacosamide Oral Solution, 10 mg/mL, enters the U.S. market with an annual market size of $57 million