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Original New Drug Application Approvals by US FDA (16-31 January 2023)

31 Jan 2023

New drug applications approved by US FDA as of 16-31 January 2023 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 (16-31 January 2023)

31 Jan 2023

BNT162b2 vax prevents delta, omicron infection in adolescents; benefits upped with booster dose

30 Jan 2023 bởi

Full vaccination with the SARS-CoV-2 BNT162b2 vaccine reduced infection and hospitalization due to the delta and omicron variants of the SARS-CoV-2 infection, with an added benefit against the omicron variant in individuals who received a booster dose, according to a national study of Singaporean adolescents.

BNT162b2 vax prevents delta, omicron infection in adolescents; benefits upped with booster dose

30 Jan 2023

$Abatacept shows promise in refractory juvenile dermatomyositis$

Abatacept shows promise in refractory juvenile dermatomyositis

30 Jan 2023

Some patients with treatment-refractory juvenile dermatomyositis (JDM) appear to respond to abatacept, as shown in a small study.

Abatacept shows promise in refractory juvenile dermatomyositis

30 Jan 2023

Aspirin, warfarin, NOACs prevent thromboembolic events in patients with Fontan circulation

30 Jan 2023

Treatment with aspirin, warfarin, and nonvitamin K oral anticoagulant (NOAC) results in a reduced risk of thromboembolic events, suggests a recent study.

Aspirin, warfarin, NOACs prevent thromboembolic events in patients with Fontan circulation

30 Jan 2023

Starting dose of CDK4/6 inhibitors linked to survival in metastatic breast cancer

30 Jan 2023

Progression-free (PFS) and overall survival (OS) are similar between age groups (≥70 and <70 years) among patients treated with cyclin-dependent kinase (CDK) 4/6 inhibitors from 2015 to 2019, with no significant differences in neutropaenia or thrombocytopaenia toxicity, reports a study.

Starting dose of CDK4/6 inhibitors linked to survival in metastatic breast cancer

30 Jan 2023

Torsemide, furosemide yield similar survival outcomes in heart failure

30 Jan 2023

Treatment with torsemide in survivors of heart failure hospitalization appears to have a similar effect on all-cause mortality over 12 months as furosemide, according to data from the open-label TRANSFORM-HF study.

Torsemide, furosemide yield similar survival outcomes in heart failure

30 Jan 2023

Switching from ARB, ACEI to sacubitril/valsartan ups angioedema risk

29 Jan 2023

New users of sacubitril-valsartan (SV) show no increased risk of angioedema when compared to users of angiotensin-converting enzyme (ACE) inhibitor and angiotensin receptor blocker (ARB), reports a study.

Switching from ARB, ACEI to sacubitril/valsartan ups angioedema risk

29 Jan 2023

Early-onset fever tied to severe cytokine release syndrome, multiple tocilizumab doses

29 Jan 2023

An earlier onset of fever appears to predict a more severe and progressive cytokine release syndrome, a life-threatening hyper-inflammatory state caused by immune effector cell therapy, suggests a study. Such condition also warrants several doses of anti-interleukin (IL)-6 therapy, such as tocilizumab.

Early-onset fever tied to severe cytokine release syndrome, multiple tocilizumab doses

29 Jan 2023

Ospemifene improves vaginal microbiome of women with vulvovaginal atrophy

29 Jan 2023

Women with vulvovaginal atrophy exhibit a less favourable vaginal microbiome than healthy postmenopausal women, but ospemifene may restore vaginal health by reducing potentially harmful bacteria, as shown in a study.

Ospemifene improves vaginal microbiome of women with vulvovaginal atrophy

29 Jan 2023

Pharmacist-led intervention improves BP control of patients on oral chemotherapy

28 Jan 2023

Patients on oral chemotherapy, who underwent a pharmacist-led hypertension management program, show improvements in blood pressure (BP) control as well as lower mean BP readings over time, reports a recent study.

Pharmacist-led intervention improves BP control of patients on oral chemotherapy

28 Jan 2023

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Original New Drug Application Approvals by US FDA (16-31 January 2023)

Original New Drug Application Approvals by US FDA (16-31 January 2023)

BNT162b2 vax prevents delta, omicron infection in adolescents; benefits upped with booster dose

BNT162b2 vax prevents delta, omicron infection in adolescents; benefits upped with booster dose

Abatacept shows promise in refractory juvenile dermatomyositis

Abatacept shows promise in refractory juvenile dermatomyositis

Aspirin, warfarin, NOACs prevent thromboembolic events in patients with Fontan circulation

Aspirin, warfarin, NOACs prevent thromboembolic events in patients with Fontan circulation

Starting dose of CDK4/6 inhibitors linked to survival in metastatic breast cancer

Starting dose of CDK4/6 inhibitors linked to survival in metastatic breast cancer

Torsemide, furosemide yield similar survival outcomes in heart failure

Torsemide, furosemide yield similar survival outcomes in heart failure

Switching from ARB, ACEI to sacubitril/valsartan ups angioedema risk

Switching from ARB, ACEI to sacubitril/valsartan ups angioedema risk

Early-onset fever tied to severe cytokine release syndrome, multiple tocilizumab doses

Early-onset fever tied to severe cytokine release syndrome, multiple tocilizumab doses

Ospemifene improves vaginal microbiome of women with vulvovaginal atrophy

Ospemifene improves vaginal microbiome of women with vulvovaginal atrophy

Pharmacist-led intervention improves BP control of patients on oral chemotherapy

Pharmacist-led intervention improves BP control of patients on oral chemotherapy