Regulatory

Zai Lab’s ZL-1310 Secures the US FDA’s Orphan Drug Designation to Treat Small Cell Lung Cancer (SCLC)

Zai Lab’s ZL-1310 Secures the US FDA’s Orphan Drug Designation to Treat Small Cell Lung Cancer (SCLC)

Shots: The US FDA has granted Orphan Drug Designation to Zai Lab’s ZL-1310 f...

Solid Biosciences’ SGT-212 Secures the US FDA’s Fast Track Designation for Treating Friedreich’s Ataxia

Solid Biosciences’ SGT-212 Secures the US FDA’s Fast Track Designation for Treating Friedreich’s Ataxia

Shots: The US FDA has granted FTD to SGT-212 for treating Friedreich’s ataxi...

The EC Approves Sanofi’s Sarclisa + standard-of-care VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

The EC Approves Sanofi’s Sarclisa + standard-of-care VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The EC has approved Sarclisa with SoC VRd (bortezomib, lenalidomide, &...

The US FDA Approves sNDA for J&J’s Spravato (esketamine) to Treat Major Depressive Disorder (MDD)

The US FDA Approves sNDA for J&J’s Spravato (esketamine) to Treat Major Depressive Disorder (MDD)

Shots: The US FDA has approved sNDA for Spravato CIII nasal spray to treat MDD pat...

Takeda Receives Health Canada’s Approval for Fruzaqla (fruquintinib) to Treat Metastatic Colorectal Cancer (mCRC)

Takeda Receives Health Canada’s Approval for Fruzaqla (fruquintinib) to Treat Metastatic Colorectal Cancer (mCRC)

Shots:  Health Canada has approved Fruzaqla to treat mCRC patients receiving...

GSK’s Jemperli Plus Chemotherapy Receives the EC’s Approval as a 1L Treatment of Primary Advanced or Recurrent Endometrial Cancer

GSK’s Jemperli Plus Chemotherapy Receives the EC’s Approval as a 1L Treatment of Primary Advanced or Recurrent Endometrial Cancer

Shots: The EC has approved Jemperli + CT (carboplatin & paclitaxel) as a 1L tr...

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