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Recent BioBlast® Updates

Approval Alert: Galderma’s Nemolizumab Approved in the UK and Switzerland

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:

Regeneron/Sanofi’s Dupixent® sBLA Accepted for Priority Review for Treating Bullous Pemphigoid

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

FDA to Review Alvotech/Teva’s BLA for Biosimilar Aflibercept

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®

Positive Ph III Results for Boan Biotech’s Denosumab Biosimilar

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),

New Indication Alert: Novo Nordisk’s Wegovy® AU-Approved for Heart Disease

Feb 17, 2025

The Australian Financial Review reports that on 17 February 2025, Novo Nordisk confirmed that Australia’s Therapeutic Goods Administration (TGA) approved an indication extension for Wegovy® (semaglutide)

Formycon to Terminate Ph 3 Trial and Pursue US-Approval of Pembrolizumab Biosimilar Based on Ph 1/Analytical Data

Feb 17, 2025

On 17 February 2025, Formycon announced that it will be prematurely terminating the “Lotus” Phase 3 trial of FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab). According to Formycon,

Approval Alert: Samsung Bioepis’ Denosumab Biosimilars Second to be Approved in EU

Feb 16, 2025

On 16 February 2025, Samsung Bioepis announced that the European Commission has approved Obodence™ (60mg pre-filled syringe) and Xbryk™ (120mg vial), biosimilars to Amgen’s Prolia® and

Approval Alert: European Commission Approves Galderma’s Nemolizumab

Feb 14, 2025

On 14 February 2025, Galderma announced that the European Commission has approved Nemluvio® (nemolizumab) for both moderate to severe atopic dermatitis and prurigo nodularis.

Approval Alert: FDA Approves Sanofi’s Merilog™/Merilog™ SoloStar as First Rapid Acting Insulin Biosimilars to Novo Nordisk’s Novolog®

Feb 14, 2025

On 14 February 2025, the FDA approved Sanofi-Aventis US’s Merilog™ (injection, 10 mL)/Merilog™ SoloStar (injection, 3 mL) (insulin-aspart-szjj), biosimilars to Novo Nordisk’s Novolog® (insulin aspart),

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Recent BioBlast® Updates

Approval Alert: Galderma’s Nemolizumab Approved in the UK and Switzerland

Regeneron/Sanofi’s Dupixent® sBLA Accepted for Priority Review for Treating Bullous Pemphigoid

FDA to Review Alvotech/Teva’s BLA for Biosimilar Aflibercept

Positive Ph III Results for Boan Biotech’s Denosumab Biosimilar

New Indication Alert: Novo Nordisk’s Wegovy® AU-Approved for Heart Disease

Formycon to Terminate Ph 3 Trial and Pursue US-Approval of Pembrolizumab Biosimilar Based on Ph 1/Analytical Data

Approval Alert: Samsung Bioepis’ Denosumab Biosimilars Second to be Approved in EU

Approval Alert: European Commission Approves Galderma’s Nemolizumab

Approval Alert: FDA Approves Sanofi’s Merilog™/Merilog™ SoloStar as First Rapid Acting Insulin Biosimilars to Novo Nordisk’s Novolog®

Celltrion’s Biosimilar Tocilizumab SC Formulation Approved in Korea

Approval Alert: CSL’s Garadacimab Approved in Europe

Approval Alert: Samsung Bioepis’ Denosumab Biosimilars Second to be Approved in US

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