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sBLA

Novartis Reports the US FDA and EMA's Acceptance of sBLA for Kymriah (tisagenlecleucel) and Granted Priority Review to Treat R/R Follicular Lymphoma

Novartis Reports the US FDA and EMA's Acceptance of sBLA for Kymriah (tisagenlecleucel) and Granted Priority Review to Treat R/R F...

  • October 29, 2021
Boehringer Ingelheim's Cyltezo (biosimilar- adalimumab) Receives the US FDA's sBLA Approval as the 1st Interchangeable Biosimilar for Multiple Chronic Inflammatory Diseases

Boehringer Ingelheim's Cyltezo (biosimilar- adalimumab) Receives the US FDA's sBLA Approval as the 1st Interchangeable Biosimilar...

  • October 18, 2021
Janssen Report Submission of sBLA to the US FDA for the Approval of Stelara (ustekinumab) to Treat Juvenile Psoriatic Arthritis

Janssen Report Submission of sBLA to the US FDA for the Approval of Stelara (ustekinumab) to Treat Juvenile Psoriatic Arthritis

  • October 11, 2021
ONO and Report Submission of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L Treatment of Unresectable Advanced or Recurrent ESCC in Japan

ONO and Report Submission of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L Treatment of Unresectable Advanced or Recurre...

  • September 14, 2021
Pfizer and BioNTech Initiate Rolling Submission of sBLA for the US FDA's Approval of Comirnaty's Booster Dose in Individuals Aged 16 Years and Older

Pfizer and BioNTech Initiate Rolling Submission of sBLA for the US FDA's Approval of Comirnaty's Booster Dose in Individuals Aged...

  • August 26, 2021
BeiGene Reports NMPA's Acceptance of sBLA for Tislelizumab (BGB-A317) to Treat Nasopharyngeal Cancer in China

BeiGene Reports NMPA's Acceptance of sBLA for Tislelizumab (BGB-A317) to Treat Nasopharyngeal Cancer in China

  • August 23, 2021
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