Regulatory

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FDA’s Oncologic Drugs Advisory Committee Recommends Earlier Treatment with Carvykti for Relapsed or Refractory Multiple Myeloma

March 18th 2024

In a unanimous decision, the committee recommended Carvykti based on promising data from the Phase III CARTITUDE-4 study, which showed a positive risk-benefit assessment.

FDA Approves Tevimbra, BeiGene’s Treatment for Adults with Unresectable or Metastatic Esophageal Squamous Carcinoma
FDA Approves Tevimbra, BeiGene’s Treatment for Adults with Unresectable or Metastatic Esophageal Squamous Carcinoma

March 15th 2024

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FDA Grants Accelerated Approval to Bristol Myers Squibb’s Breyanzi for Relapsed or Refractory CLL, SLL

March 15th 2024

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FDA Approves First Treatment for Noncirrhotic Nonalcoholic Steatohepatitis (NASH)

March 15th 2024

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FDA Approves Expanded Indication for Praluent to Lower LDL-C in Pediatric Patients with HeFH

March 11th 2024

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