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FDA launches wide probe into CAR-T therapy safety

The FDA has announced it will start an investigation into the safety of CAR-T therapies, after becoming concerned that they may be linked to the development of T-cell canc

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FDA okays first therapy for desmoid tumours from SpringWorks

Pfizer spin-out SpringWorks Therapeutics has its first approved product after getting a green light from the FDA for Ogsiveo, the first-ever therapy for a rare type of non

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Xtandi cleared by FDA for earlier-stage prostate cancer

Already a mainstay of prostate cancer therapy, Pfizer and Astellas’ Xtandi has picked up a new approval in the US that could reinvigorate the drug, even as it approaches i

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FDA’s Janet Woodcock will step down early next year

Janet Woodcock will bring a career at the FDA spanning almost four decades to a close next year, retiring from her current role as principal deputy commissioner of the reg

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AZ first to AKT finish line, but FDA clears narrow label

AstraZeneca has claimed FDA approval for its first-in-class pan-AKT inhibitor capivasertib, getting a green light for the drug as a treatment for breast cancer, but with a

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FTC challenges dozens of ‘improper’ US drug patents

The financial regulator in the US has sent letters to 10 companies that it claims have improperly listed patents in the FDA’s ‘Orange Book’ in order to block generic rival

FDA launches wide probe into CAR-T therapy safety

FDA okays first therapy for desmoid tumours from SpringWorks

Xtandi cleared by FDA for earlier-stage prostate cancer

FDA’s Janet Woodcock will step down early next year

AZ first to AKT finish line, but FDA clears narrow label

FTC challenges dozens of ‘improper’ US drug patents

CDC panel votes to scrap hepatitis B birth dose advice

How to meet your physicians where they are online

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