With clinician approval, reproductive-age patients prescribed isotretinoin-containing drugs for acne may complete required pregnancy testing at home or in other non-medical settings, the FDA announced ...
There is enough experience with the first wave of autologous CAR-T therapies targeting CD19 and BCMA to allow strict rules ensuring their safe use to be relaxed, according to the FDA. The US regulator ...
The FDA has approved long-awaited changes to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) to minimize the burden on patients, prescribers, and pharmacies while protecting safe use of the ...
The US FDA can now require companies to develop a risk evaluation and mitigation strategy (REMS) for therapeutic products. Bethan Hughes investigates the recent evolution of risk-management strategies ...
AstraZeneca has been successful at rolling out its long-acting complement C5 inhibitor Ultomiris in the uses approved for its predecessor Soliris – until now, that is. The drugmaker confirmed this ...
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