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Feb 20, 2025
On 20 February 2025, Genmab announced that Japan’s Ministry of Health, Labour and Welfare has approved Epkinly® (epcoritamab) for the treatment of patients with relapsed or refractory (R/R)
Feb 20, 2025
On 20 February 2025, Bayer announced that Health Canada has approved Eylea® HD (aflibercept injection, 8mg) in a pre-filled syringe with integrated OcuClick™ dosing system for the treatment of nAMD and diabetic macular oedema (DME).
Feb 19, 2025
On 19 February 2025, Celltrion announced that the European Commission has approved Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for the same indications as the reference medicines.
Feb 19, 2025
On 19 February 2025, Shanghai Henlius Biotech announced that its HANBEITAI, biosimilar to Roche/Genentech’s Avastin® (bevacizumab) has received marketing approval from Bolivia’s Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) under the trade name Longiva™.
Feb 19, 2025
Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for the month of January. Among the applications for new medicines to be
Feb 18, 2025
On 18 February 2025, Celltrion announced that the European Commission has approved Eydenzelt® (CT-P42), biosimilar to Bayer/Regeneron’s Eylea® (aflibercept), for the treatment of multiple retinal
Feb 18, 2025
On 18 February 2025, Biocon Biologics announced that the European Commission has granted marketing authorisation for Yesintek®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab). Yesintek®
Feb 18, 2025
On 18 February 2025, Merus announced that the FDA has granted Breakthrough Therapy Designation (BTD) to petosemtamab in combination with pembrolizumab for the first-line treatment
Feb 18, 2025
On 18 February 2025, Galderma announced that Nemluvio® (nemolizumab) for subcutaneous administration has been approved in the UK and Switzerland for two indications:
Feb 18, 2025
On 18 February 2025, Regeneron and Sanofi announced that the US FDA has accepted their sBLA for priority review of Dupixent® (dupilumab) for the targeted treatment of bullous pemphigoid (BP). The FDA’s decision is expected by 20 June 2025. If approved, Dupixent® will be the first and only
Feb 18, 2025
On 18 February 2025, Alvotech and Teva announced that the US FDA has accepted for review a Biologics Licence Application (BLA) for Alvotech-developed AVT06, biosimilar to Regeneron’s Eylea®
Feb 17, 2025
On 17 February 2025, Boan Biotech announced that the Journal of Bone Oncology published Phase III trial results for its biosimilar denosumab (Boluojia®/BA1102, formerly code-named LY01011),
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