New drug applications approved by US FDA as of 01 - 15 November 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 patients with atrial fibrillation (AF) and stable coronary artery disease (CAD), rivaroxaban monotherapy is noninferior to combination treatment with an antiplatelet therapy in terms of cutting the risk of cardiovascular events and mortality, according to data from the AFIRE trial.
The LAMA* aclidinium bromide was similarly effective in reducing exacerbation rate without raising the risk of MACE** or all-cause mortality regardless of recent history of exacerbations in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD), according to a subgroup analysis of the phase IV ASCENT-COPD*** trial presented at the CHEST 2019 Annual Meeting.
The addition of pertuzumab to a trastuzumab-docetaxel regimen in the neoadjuvant setting improved total pathological complete response (tpCR) rates in Asian women with early or locally advanced ERBB2-positive breast cancer, according to the phase III PEONY trial from China.
Quality of life (QoL) in breast cancer patients worsens 2 years following diagnosis with different courses by treatment received, a study has found. Specifically, endocrine therapy exerts a major detrimental impact on QoL as opposed to chemotherapy having a transient negative effect in postmenopausal patients.
Nonvitamin K antagonist oral anticoagulants (NOACs) appear to confer more clinical benefits to elderly patients with atrial fibrillation (AF) than vitamin K antagonist anticoagulants (VKAs), suggests a study, adding that this is primarily driven by the lower rates of major bleeding.
Multiple intralesional injections with purified protein derivative (PPD) leads to faster clearance of common warts compared with a single injection, although the latter is better tolerated, as shown in the results of an open‐label, superiority trial.
Use of direct acting antivirals (DAAs) to treat hepatitis C virus (HCV) infection is feasible during pregnancy, as these drugs are highly effective and treatment duration is relatively short, according to a study. In addition, DAA treatment helps improve maternal health and prevent vertical transmission.