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                Vaccines, Blood & Biologics

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          CBER 2024 Orphan ApprovalsVaccines, Blood & Biologics CBER 2024 Orphan Approvals
  
  	
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    PrintThis list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval in reverse chronological order.

Trade Name/ Proper Name
			Indication
			Manufacturer/License Number
			Approval Date**CASGEVY**
			Indicated for the treatment of patients 12 years of age and older with transfusion-dependent beta thalassemia (TDT).
			Vertex Pharmaceuticals Inc
			1/16/24

                                                                                  Content current as of:
      01/19/2024
              
              
Regulated Product(s)
		 Biologics
			  			     			  						              
			
			 
			  Blood ProductsVaccines, Blood & Biologics

          
                        Infectious Disease Tests


                        Fecal Microbiota Products
          Allergenics
          Blood & Blood Products
          Blood Donor Screening
          Cellular & Gene Therapy Products
          Development & Approval Process (CBER)
          Guidance, Compliance & Regulatory Information (Biologics)
          International Activities
          News & Events (Biologics)
          Resources for You (Biologics)
          Safety & Availability (Biologics)
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          Vaccines
          Xenotransplantation
 
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