Lihui Bai on FDA Approval

Henlius Receives Orphan-Drug Designation for HLX22 (anti-HER2 mAb) for Gastric Cancer

On March 19, 2025, Shanghai Henlius Biotech announced that the FDA has granted Orphan Drug Designation for HLX22, an anti-HER2 monoclonal antibody, for the treatment of gastric cancer. HLX22 binds to HER2 extracellular...more

3/28/2025 / Biotechnology , Cancer , Clinical Trials , FDA Approval , Food and Drug Administration (FDA) , Orphan Drugs , Pharmaceutical Industry , Prescription Drugs , Regulatory Requirements

FDA Approves Sandoz’s ENVEEZU™ (aflibercept-abzv)

On August 12, 2024, Sandoz announced that the FDA has approved ENVEEZUTM (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection. ENVEEZUTM is indicated for the treatment of neovascular (wet)...more

8/15/2024 / Biosimilars , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

FDA Approves Amgen’s BKEMV, the First Eculizumab Biosimilar

On May 28, 2024, the FDA approved Amgen’s BKEMV (eculizumab-aeeb), the first approved biosimilar of Alexion’s SOLIRIS (eculizumab). BKEMV was approved by the FDA as a 300 mg/30 mL (10 mg/mL) injection, for intravenous...more

6/10/2024 / Amgen , Biosimilars , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

FDA Approves First Gene Therapy to Treat Children with Metachromatic Leukodystrophy

On March 18, 2024, the FDA approved Orchard Therapeutics’ LENMELDY, the first approved gene therapy for the treatment of children with metachromatic leukodysrophy (MLD)....more

3/28/2024 / FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

FDA Approves First Cellular Therapy for Treatment of Unresectable or Metastatic Melanoma

On February 16, 2024, the FDA approved Iovance’s AMTAGVI, the first approved cellular therapy for the treatment of adult patients with unresectable or metastatic melanoma....more

2/23/2024 / FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

Recent Biosimilar Approvals

On December 7, 2023, Bio-Thera Solutions, Ltd. announced that the FDA has approved AVZIVI (bevacizumab-tnjn), a biosimilar referencing Genentech’s AVASTIN...more

12/15/2023 / Biologics , Biosimilars , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Prescription Drugs

Biogen Announces FDA Approval of TOFIDENCE, a Tocilizumab Biosimilar Referencing ACTEMRA

On September 29, 2023, Biogen announced the FDA approval of TOFIDENCE (tocilizumab-bavi) intravenous formulation which is the first tocilizumab biosimilar approved by the FDA in the United States. TOFIDENCE is...more

10/5/2023 / Biogen Idec , Biosimilars , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

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