FDA approval

FDA approves the first Tysabri biosimilar for MS and Crohn’s disease

The first biosimilar of Biogen’s Tysabri (natalizumab) is set to hit the market with approval from the US Food and…

Regeneron’s Veopoz scores FDA approval for rare immune disease

Regeneron Pharmaceuticals has received US Food and Drug Administration (FDA) approvals for two of its drugs, namely Veopoz (pozelimab-bbfg) and…

FDA approves Delcath’s liver-directed therapy for metastatic uveal melanoma

Delcath Systems’ Hepzato Kit (melphalan/hepatic delivery system) has been approved by the US Food and Drug Administration (FDA) for treating…

Pfizer’s Elrexfio tries to challenge Janssen in RRMM with FDA approval

Pfizer’s Elrexfio (elranatamab-bcmm) has received accelerated approval from the US Food and Drug Administration (FDA) to treat adults with relapsed…

FDA approves Talvey for heavily pre-treated multiple myeloma

US Food and Drug Administration (FDA) has approved Talvey (talquetamab-tgvs) for the treatment of refractory or relapsed multiple myeloma in…

Bayer’s new haemophilia A drug obtains FDA approval

Bayer has received approval from the US Food and Drug Administration (FDA) for its new haemophilia A drug Jivi (BAY94-9027)…