News & Updates

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

Abatacept shows promise in refractory juvenile dermatomyositis

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

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

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

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

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.

Torsemide, furosemide yield similar survival outcomes in heart failure

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.

The role of oral antivirals in COVID-19 treatment: Who, when, and how?

Though most countries have eased pandemic restrictions, there is no room for complacency in managing COVID-19, which continues to cause significant morbidity and mortality.

At a recent symposium, esteemed experts Dr Roger Paredes, Head of Department of Infectious Diseases at the Hospital Universitari Germans Trias i Pujol, Badalona, Catalonia, Spain, and Dr Nicola Petrosillo, Head of the Infection Prevention and Control and Infectious Disease Service at University Hospital Campus Bio-Medico, Rome, Italy, gave global perspectives on the continuing unmet needs in the COVID-19 outpatient landscape and discussed the role of antiviral treatment options in patients at risk of progressing to severe COVID-19. Dr Petrick Periyasamy, Head of Infectious Diseases Unit, Medical Department, UKM Medical Centre, Kuala Lumpur, Malaysia, chaired the session.

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

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.

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

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.

Ospemifene improves vaginal microbiome of women with vulvovaginal atrophy

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.