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FDA Requests Class-Wide Boxed Warning for CAR T-Cell Agents Regarding Secondary T-Cell Malignancy Risk

The FDA has called to add a class-wide boxed warning for CAR T-cell therapies to alert patients of the risk of developing secondary T-cell malignancies.

United statesUnited kingdomNicole verdunKorean ministry of foodRegulatory agencyEuropean union medicines agencyAvailability communicationsOffice of therapeutic productsNew england journalBiologics evaluationTherapeutic productsEuropean unionEuropean medicines agencySouth korean ministryCart cell therapy

IN FOCUS: From Telegram to doctor shopping - how easy access to prescription drugs can fuel addiction

Narratives about drug addiction in Singapore tend to focus on illegal substances. Less attention is paid to prescription medication - but addiction to it should be taken as seriously, as CNA learns.

Health productsHealth products therapeutic regulationsSingapore health sciences authorityHealth sciences authorityHealth products actTherapeutic productsStraits timesDrug addictionIn focus

FDA s CoGenT Global Revolutionizing Gene Therapy Regulations

FDA s CoGenT Global Revolutionizing Gene Therapy Regulations
natlawreview.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from natlawreview.com Daily Mail and Mail on Sunday newspapers.

United statesUnited kingdomSan franciscoMark janPeter marksOffice of tissuesOncology centerOffice of therapeutic productsDrug administrationSolution through international collaborationWorld health organizationInternational council for harmonisationAlliance for regenerative medicineEuropean unionReadiness pilot programGo to guide

FDA clears first CRISPR treatment for a second disease, beta thalassemia

FDA clears first CRISPR treatment for a second disease, beta thalassemia
localnews8.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from localnews8.com Daily Mail and Mail on Sunday newspapers.

United statesNicole verdunBrenda goodmanDrug administrationOffice of therapeutic productsWarner brosDiscovery companyCable news network incTherapeutic productsBiologics evaluationBoston childrenNews network

FDA Clears Sickle Cell Drug to Treat Another Blood Disorder

Casgevy, a groundbreaking treatment approved to treat sickle cell disease in December, has now been approved to treat another inherited blood disorder.

United statesNicole verdunDrug administrationOffice of therapeutic productsHealthday newsTherapeutic productsBiologics evaluationBoston childrenBlood disordersSfda approvalsSickle cell anemia