Daniel Farraye

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Latest Posts › FDA Approval

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Biocon Regulatory Approval Updates in the U.S. and Europe: Insulin Aspart and Denosumab

On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection), 100 units/mL, as the first and...more

7/30/2025 / Biocon , Biosimilars , Biotechnology , EU , European Commission , FDA Approval , Food and Drug Administration (FDA) , Generic Drugs , Pharmaceutical Industry , Prescription Drugs

FDA Approves Celltrion’s STEQEYMA (ustekinumab-stba)

On December 18, 2024, Celltrion announced that the FDA has approved its ustekinumab biosimilar, STEQEYMA (ustekinumab-stba), referencing Jannsen’s STELARA....more

1/7/2025 / Biosimilars , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

Accord Biopharma Announces FDA Approval of IMULDOSA (ustekinumab-srlf)

On October 14, 2024, Accord BioPharma, Inc. announced that the FDA has approved IMULDOSA (ustekinumab-srlf), a biosimilar to Johnson & Johnson’s STELARA (ustekinumab), indicated for the treatment of chronic...more

10/25/2024 / Biotechnology , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Patents , Pharmaceutical Industry

FDA Approves Moderna’s mRESVIA Vaccine

On May 31, 2024, Moderna announced that the FDA has approved its respiratory syncytial virus vaccine (“RSV”), mRESVIA (mRNA-1345). The vaccine was designed to protect adults from lower respiratory tract disease caused...more

6/7/2024 / FDA Approval , Food and Drug Administration (FDA) , Health Care Providers , Pharmaceutical Industry , Vaccinations

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