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New drug applications approved by US FDA as of 01-15 January 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.

Original New Drug Application Approvals by US FDA (01 - 15 January 2022)

Percutaneous ethanol injection shrinks benign cystic thyroid nodules

Treatment with percutaneous ethanol injection (PEI) appears to produce marked reductions in the volume of benign cystic thyroid nodules, with the reduction evident at 6 months post-treatment and stable over time, according to the results of a meta-analysis.

Percutaneous ethanol injection shrinks benign cystic thyroid nodules

Zuranolone for sleeplessness promising in early study

The orally bioavailable, investigational neuroactive steroid zuranolone appears to be beneficial in the treatment of insomnia, producing improvements in sleep measures, including sleep efficiency, duration of awakenings, and total sleep time in adults, according to the results of a phase I study.

Zuranolone for sleeplessness promising in early study

19 Jan 2022

Ibrutinib add-on to obinutuzumab sustains PFS benefit in CLL/SLL

19 Jan 2022 bởi

Adding ibrutinib to obinutuzumab in the first-line setting sustains progression-free survival (PFS) benefit in patients with chronic lymphocytic leukaemia (CLL)/small lymphocytic leukaemia (SLL), including patients with high-risk genomic features, according to the ﬁnal analysis of the iLLUMINATE* trial.

Ibrutinib add-on to obinutuzumab sustains PFS benefit in CLL/SLL

Fluvoxamine may prevent COVID-19 hospitalization

Treatment with the selective serotonin reuptake inhibitor fluvoxamine may prevent hospitalization in outpatients presenting with symptoms of COVID-19 who have a high risk for disease progression, according to results of the TOGETHER trial.

Fluvoxamine may prevent COVID-19 hospitalization

18 Jan 2022

VTE in cancer patients: Does blood type matter?

Non-O blood type appears to be a risk factor for cancer-associated venous thromboembolism (VTE), particularly in patients who have cancer types with low to intermediate thrombotic risk, according to data from the Cancer and Thrombosis Study (CATS) presented at ASH 2021.

VTE in cancer patients: Does blood type matter?

$Tocilizumab effective in refractory joint, skin involvement in systemic sclerosis$

Tocilizumab effective in refractory joint, skin involvement in systemic sclerosis

Interleukin-6 inhibition by tocilizumab (TCZ) leads to improvements in refractory joint and skin involvement regardless of systemic sclerosis (SSc) disease duration or subtype, reports a study.

Tocilizumab effective in refractory joint, skin involvement in systemic sclerosis

Can atorvastatin save COVID-19 patients in intensive care?

Use of atorvastatin in adults with COVID-19 admitted to the intensive care unit (ICU) is safe but does not result in a marked decrease in the composite of venous or arterial thrombosis, treatment with extracorporeal membrane oxygenation, or all-cause mortality, a study has shown.

Can atorvastatin save COVID-19 patients in intensive care?

18 Jan 2022

Sunshine vitamin, calcium may help avert bone loss associated with AIs

Supplementation with vitamin D, otherwise called sunshine vitamin, and calcium may help women with breast cancer protect against bone loss associated with aromatase inhibitors (AIs), suggests a 5-year follow-up study from Brazil.

Sunshine vitamin, calcium may help avert bone loss associated with AIs