Regulatory

Amgen’s Imdelltra (Tarlatamab-dlle) Receives the US FDA’s Approval to Treat Extensive-Stage Small Cell Lung Cancer

Amgen’s Imdelltra (Tarlatamab-dlle) Receives the US FDA’s Approval to Treat Extensive-Stage Small Cell Lung Cancer

Shots: The US FDA has granted accelerated approval to Amgen’s Imdelltra (DLL...

BMS Reports the US FDA’s Accelerated Approval of Breyanzi for Treating Follicular Lymphoma (FL)

BMS Reports the US FDA’s Accelerated Approval of Breyanzi for Treating Follicular Lymphoma (FL)

Shots: The US FDA’s accelerated approval of Breyanzi for r/r FL adults treat...

The US FDA Rejects Dynavax’ Four-Dose Heplisav-B Regimen for Adults on Hemodialysis

The US FDA Rejects Dynavax’ Four-Dose Heplisav-B Regimen for Adults on Hemodialysis

Shots: The US FDA issued a Complete Response Letter (CRL) for the four-dose Heplis...

Roche Receives the US FDA’s Approval for HPV Self-Collection Solutions for Cervical Cancer

Roche Receives the US FDA’s Approval for HPV Self-Collection Solutions for Cervical Cancer

Shots: Roche has received the US FDA’s approval for its human papillomavirus...

Merus’ Petosemtamab Receives the US FDA’s Breakthrough Therapy Designation for Head and Neck Squamous Cell Carcinoma

Merus’ Petosemtamab Receives the US FDA’s Breakthrough Therapy Designation for Head and Neck Squamous Cell Carcinoma

Shots: The BTD was granted to petosemtamab for treating recurrent/metastatic HNSCC...

Zai Lab’s Augtyro Receives the NMPA’s Approval to Treat Non-Small-Cell Lung Cancer (NSCLC)

Zai Lab’s Augtyro Receives the NMPA’s Approval to Treat Non-Small-Cell Lung Cancer (NSCLC)

Shots: The NMPA has approved Augtyro for treating locally advanced or metastatic R...

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