• US FDA Approval

Lupin’s Inhalation Research Center, Florida receives EIR from U.S. FDA

Mumbai, March 30, 2020: Pharma major Lupin Limited (Lupin) today announced the receipt of the Establishment Inspection Report (EIR) from the…

• Health Care

Lupin Bioresearch Centre completes fifth successful U.S. FDA inspection

Mumbai, Baltimore, June 05, 2019: Pharma major Lupin Limited (Lupin) announced the successful completion of the United States Food and Drug…

• Archives

Eisai and Imbrium Therapeutics Announce U.S. FDA Filing Acceptance of New Drug Application for Lemborexant for the Treatment of Insomnia

New Delhi, March 14, 2019: Eisai Co., Ltd. and Imbrium Therapeutics L.P., a clinical-stage biopharmaceutical company and operating subsidiary of Purdue…

U.S. FDA Approves Mylan and Biocon’s Fulphila™ (pegfilgrastim-jmdb), the First Biosimilar to Neulasta®

Fulphila is expected to be the first biosimilar pegfilgrastim available in the U.S. to help patients with nonmyeloid cancers reduce…