New drug applications approved by US FDA as of 01 - 15 August 2019 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.
In heart failure patients with reduced ejection fraction (HFrEF) and renal impairment or hypotension, sacubitril/valsartan has been shown to be an effective angiotensin receptor and neprilysin inhibition (ARNI) intervention, reports a recent study.
Belimumab for systemic lupus erythematosus (SLE) has demonstrated a stable safety profile over 8 years of follow-up, with no new safety signal and minimal organ damage progression, according to data from an extension study involving non-American patients who completed the phase III BLISS*-52 or BLISS-76 trials.
The immunotherapeutic human papillomavirus (HPV) vaccine tipapkinogen sovacivec (TS) provided complete histologic resolution of cervical intraepithelial neoplasia (CIN) grade 2/3, offering a potential nonsurgical option for cervical precancerous lesions which could stretch to other HPV-associated precursors or cancers in the future, a new study shows.
The histone deacetylase inhibitor tucidinostat, when used in combination with exemestane for treating patients with advanced, HR-positive, HER2-negative breast cancer, prolongs progression-free survival and substantially increases overall response and clinical benefit, while having a manageable safety profile, as shown in the results of the phase III ACE trial.
Treatment with nebivolol yields more favourable changes in 24-hour, intradialytic and daytime systolic and diastolic blood pressure variability in patients with intradialytic hypertension, a study has found.
On 8 August, the first town hall held by the Ministry of Health (MOH) with members of the pharmacy profession took place in Putrajaya. Over 500 pharmacists from across the country and from different areas of practice—community and hospital, public and private, academy and industry—converged to fill the auditorium for the chance to engage in direct dialogue with MOH.
Adding pertuzumab to trastuzumab plus an aromatase inhibitor (AI) improves progression-free survival (PFS) in patients with HER2-positive metastatic or locally advanced breast cancer, the phase II PERTAIN study has shown.
At the recent GLYCEMIC GUARDIANS™ dinner symposium, three eminent speakers spoke on theindispensable role of medical nutrition therapy (MNT) in improving outcomes for patients with type2 diabetes (T2D).