Regulatory

Bayer Submits NDA of Elinzanetant, Seeking Approval in the US for Vasomotor Symptoms Treatment

Bayer Submits NDA of Elinzanetant, Seeking Approval in the US for Vasomotor Symptoms Treatment

Shots: Bayer has submitted NDA of elinzanetant (dual NK-1 & 3 receptor antagon...

GSK Reports the US FDA’s Expanded Approval of Jemperli Plus Chemotherapy for Treating Endometrial Cancer

GSK Reports the US FDA’s Expanded Approval of Jemperli Plus Chemotherapy for Treating Endometrial Cancer

Shots: The US FDA has approved Jemperli (dostarlimab) + CT (carboplatin & pacl...

Innovent Reports the NMPA’s NDA Acceptance of Mazdutide to Treat Type 2 Diabetes

Innovent Reports the NMPA’s NDA Acceptance of Mazdutide to Treat Type 2 Diabetes

Shots: The NMPA has accepted 2nd NDA of mazdutide (a glucagon-like peptid...

Johnson & Johnson’s Darzalex Faspro Quadruplet Combination Gains the US FDA’s Approval to Treat Multiple Myeloma (MM)

Johnson & Johnson’s Darzalex Faspro Quadruplet Combination Gains the US FDA’s Approval to Treat Multiple Myeloma (MM)

Shots: The US FDA has approved Darzalex Faspro (daratumumab & hyaluronidase-fi...

Verastem Oncology’s Avutometinib Gains the US FDA’s Orphan Drug Designation to Treat Pancreatic Cancer

Verastem Oncology’s Avutometinib Gains the US FDA’s Orphan Drug Designation to Treat Pancreatic Cancer

Shots: The US FDA has granted ODD to avutometinib + defactinib for treating pancre...

Roche’s Vabysmo (Faricimab) Receives the EC’s Approval to Treat Retinal Vein Occlusion (RVO)

Roche’s Vabysmo (Faricimab) Receives the EC’s Approval to Treat Retinal Vein Occlusion (RVO)

Shots: The EC’s approval of Vabysmo for visual impairment caused by macular...

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