Regulatory

Johnson & Johnson Reports the US FDA ODAC’s Recommendation of Carvykti for Treating Relapsed/Refractory Multiple Myeloma

Johnson & Johnson Reports the US FDA ODAC’s Recommendation of Carvykti for Treating Relapsed/Refractory Multiple Myeloma

Shots: J&J’s Carvykti has received recommendation from the US FDA’...

Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) Receives the US FDA’s Approval to Treat NASH with Liver Fibrosis

Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) Receives the US FDA’s Approval to Treat NASH with Liver Fibrosis

Shots: The US FDA has granted accelerated approval to Rezdiffra for treating nonci...

The US FDA Grants Approval to BeiGene’s Tevimbra to Treat Advanced or Metastatic Esophageal Squamous Cell Carcinoma

The US FDA Grants Approval to BeiGene’s Tevimbra to Treat Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Shots: BeiGene’s Tevimbra has received the US FDA’s approval as a mono...

BMS’ Breyanzi Receives the US FDA’s Approval for the Treatment of R/R Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

BMS’ Breyanzi Receives the US FDA’s Approval for the Treatment of R/R Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymp...

Shots: BMS’ Breyanzi (lisocabtagene maraleucel; liso-cel) has received accel...

Daiichi Sankyo Submits NDA of Datopotamab Deruxtecan to the MHLW for the Treatment of Advanced Breast Cancer

Daiichi Sankyo Submits NDA of Datopotamab Deruxtecan to the MHLW for the Treatment of Advanced Breast Cancer

Shots: Daiichi Sankyo has reported the NDA submission of datopotamab deruxtecan (D...

Pfizer’s Prevenar 20 Receives EC’s Approval for the Protection Against Pneumococcal Disease in Pediatric Population

Pfizer’s Prevenar 20 Receives EC’s Approval for the Protection Against Pneumococcal Disease in Pediatric Population

Shots: Pfizer’s 20-valent pneumococcal conjugate vaccine, Prevenar 20, has r...

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