News &amp; Updates

Original New Drug Application Approvals by US FDA (16-31 December 2024)

New drug applications approved by US FDA as of 16-31 December 2024 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 December 2024)

Mavacamten obviates long-term need for invasive septal reduction therapy in obstructive HCM

07 Jan 2025 by

Treatment with the allosteric cardiac myosin inhibitor mavacamten in severely symptomatic patients with obstructive HCM allows for the deferral of invasive SRT for nearly 2.5 years, as shown in the end-of-trial results of VALOR-HCM presented at AHA 2024

Mavacamten obviates long-term need for invasive septal reduction therapy in obstructive HCM

Coffee perks up brain function in AF patients

Daily coffee drinking may provide atrial fibrillation (AF) patients with cognitive benefits, as suggested in a study.

Coffee perks up brain function in AF patients

CPAP still valuable for OSA patients despite absence of CV benefits in RCTs

The reasons why continuous positive airway pressure (CPAP) treatment has not been shown to reduce cardiovascular (CV) events in randomized trials on obstructive sleep apnoea (OSA) are multifaceted. However, research still suggests that such patients can benefit from CPAP, according to an evidence review presented at APSR 2024.

CPAP still valuable for OSA patients despite absence of CV benefits in RCTs

Corticosteroid phobia tied to poor treatment adherence in chronic hand eczema

Topical corticosteroid (TCS) phobia (TOPICOP) commonly exists among patients with chronic hand eczema (CHE) and often leads to poor treatment adherence, suggests a recent study.

Corticosteroid phobia tied to poor treatment adherence in chronic hand eczema

06 Jan 2025

Palbociclib plus ET prolongs survival in metastatic breast cancer

First-line endocrine therapy (ET) plus palbociclib (palb/ET) performs better than mono-chemotherapy in improving time to treatment failure (TTF) and progression-free survival (PFS) in women with hormone receptor-positive (HR+), HER2-negative metastatic breast cancer (mBC), as shown by the results of the phase III PADMA trial.

Palbociclib plus ET prolongs survival in metastatic breast cancer

06 Jan 2025

T-DXd improves PFS in breast cancer with rapid progression

Treatment with trastuzumab deruxtecan (T-DXd) results in longer progression-free survival (PFS) in patients with hormone receptor–positive, HER2-low or HER2-ultralow metastatic breast cancer (mBC) compared with physician’s choice of chemotherapy, according to the results of the phase III DESTINY-Breast06 study presented at SABCS 2024. In addition, no new safety signals have been identified.

T-DXd improves PFS in breast cancer with rapid progression

06 Jan 2025

Gestational hypertension, preeclampsia, and eclampsia associated with future neurological disorders

Gestational hypertension, preeclampsia, and eclampsia were associated with an increased risk of new-onset migraine, headache, epilepsy, sleep disorder, or mental fatigue within months to years after giving birth, a Swedish study found.

Gestational hypertension, preeclampsia, and eclampsia associated with future neurological disorders

Vitamin D may protect against young-onset ischaemic stroke

Vitamin D may protect against young-onset ischaemic stroke through preventing atrial fibrillation (AF), a University of Hong Kong (HKU) study on Southern Chinese has found.

Vitamin D may protect against young-onset ischaemic stroke