Regulatory

Regeneron and Sanofi Report the US FDA Acceptance of sBLA for Priority Review of Dupixent to Treat Eosinophilic Esophagitis in Children Aged 1-11Years

Regeneron and Sanofi Report the US FDA Acceptance of sBLA for Priority Review of Dupixent to Treat Eosinophilic Esophagitis in Chi...

Shots: The US FDA has accepted the sBLA for Priority Review of Dupixent to treat c...

AbbVie and Genmab Receive EC’s Conditional Marketing for Tepkinly (epcoritamab) to Treat Relapsed or Refractory Diffuse Large B-cell Lymphoma

AbbVie and Genmab Receive EC’s Conditional Marketing for Tepkinly (epcoritamab) to Treat Relapsed or Refractory Diffuse Large B-ce...

Shots: The EC has granted conditional marketing authorization for Tepkinly as a mo...

Genmab Receives MHLW Approval for Epkinly (epcoritamab) for Adults Patients with Large B-Cell Lymphoma

Genmab Receives MHLW Approval for Epkinly (epcoritamab) for Adults Patients with Large B-Cell Lymphoma

Shots: The MHLW has approved Epkinly (T-cell engaging bispecific Ab) for adult pat...

Sanofi Receives the MHLW’s Marketing Authorization for Altuviiio to Treat Hemophilia A

Sanofi Receives the MHLW’s Marketing Authorization for Altuviiio to Treat Hemophilia A

Shots: Sanofi’ Altuviiio, a high-sustained factor VIII replacement therapy r...

Henlius Reports the NMPA Acceptance of NDA for Hansizhuang (serplulimab) to Treat Esophageal Squamous Cell Carcinoma

Henlius Reports the NMPA Acceptance of NDA for Hansizhuang (serplulimab) to Treat Esophageal Squamous Cell Carcinoma

Shots: The NMPA has accepted the NDA for a new indication of Hansizhuang as 1L tre...

Boehringer Ingelheim and Eli Lilly Receive the US FDA’s Approval of Jardiance (empagliflozin) for Adults with Chronic Kidney Disease

Boehringer Ingelheim and Eli Lilly Receive the US FDA’s Approval of Jardiance (empagliflozin) for Adults with Chronic Kidney Disea...

Shots: The US FDA has approved Jardiance (10mg) to reduce the risk of sustained de...

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