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Original New Drug Application Approvals by US FDA (16-31 December 2022)

New drug applications approved by US FDA as of 16 - 31 December 2022 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

Daunorubicin for newly diagnosed AML: Does more equate to better outcomes?

In acute myeloid leukaemia (AML) patients who received the 7+3* induction, a higher daunorubicin dose or a double induction did not seem to yield better outcomes, findings from the two-part phase III SAL Dauno-Double trial suggest.

RAS inhibitor discontinuation of no help in slowing kidney decline

Stopping treatment with renin–angiotensin system (RAS) inhibitors in patients with advanced chronic kidney disease does not appear to raise the levels of estimated glomerular filtration rate (eGFR) or decelerate its decline, according to a study.

Heavy coffee drinking poses CVD mortality risk in presence of severe hypertension

Individuals with severe hypertension may do well to refrain from drinking too much coffee, as it contributes to an increased risk of cardiovascular disease (CVD) death, a study has found.

TACE + apatinib: A potential new strategy for intermediate/advanced HCC?