Regulatory

China’s NMPA Approves Akeso's Ebdarokimab (IL-12/IL-23 Dual-Targeted mAb) for Moderate to Severe Plaque Psoriasis

China’s NMPA Approves Akeso's Ebdarokimab (IL-12/IL-23 Dual-Targeted mAb) for Moderate to Severe Plaque Psoriasis

Shots: Akeso’s ebdarokimab has received NMPA approval for the treatment of m...

The US FDA Accepts sBLA Priority Review for Regeneron's EYLEA HD in Macular Edema Following RVO and Monthly Dosing In Approved Indications

The US FDA Accepts sBLA Priority Review for Regeneron's EYLEA HD in Macular Edema Following RVO and Monthly Dosing In Approved Ind...

Shots: Regeneron reported the US FDA acceptance for its priority review of the sBL...

InnoCare Pharma Reports NMPA’s NDA Acceptance of Zurletrectinib to Treat NTRK Fusion-Positive Solid Tumors

InnoCare Pharma Reports NMPA’s NDA Acceptance of Zurletrectinib to Treat NTRK Fusion-Positive Solid Tumors

Shots: China’s NMPA has accepted NDA of zurletrectinib (ICP-723) for the tre...

Neurelis’ Valtoco Receives the US FDA’s Approval for Acute Treatment of Seizure Clusters

Neurelis’ Valtoco Receives the US FDA’s Approval for Acute Treatment of Seizure Clusters

Shots: The US FDA has approved Valtoco for short-term treatment of acute repetitiv...

Eisai, Biogen and BioArctic Report the EC’s Approval of Leqembi (lecanemab) for Early Alzheimer’s Disease

Eisai, Biogen and BioArctic Report the EC’s Approval of Leqembi (lecanemab) for Early Alzheimer’s Disease

Shots: The EC has approved Leqembi for the treatment of early Alzheimer&rsquo...

Roche's Columvi (Glofitamab) Regimen Receives the EC’s Approval to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Roche's Columvi (Glofitamab) Regimen Receives the EC’s Approval to Treat R/R Diffuse Large B-Cell Lymphoma (DLBCL)

Shots: The EC has granted full approval to Columvi + GemOx for ASCT-ineligible r/r...

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