New drug applications approved by US FDA as of 16 - 31 March 2020 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.
Proton pump inhibitors (PPIs) may increase susceptibility to osteoporotic fractures in elderly women as compared with histamine-2 receptor antagonists (H2RAs), especially those who have used PPIs for at least a year, a recent study in Korea has found.
The addition of the epidermal growth factor receptor (EGFR) inhibitor cetuximab (CTX) to chemotherapy (CT) did not offer an overall survival (OS) benefit in patients with resectable colorectal liver metastasis (CRLM) compared with CT alone, updated results of the New EPOC trial has shown.
A triple fixed combination of bimatoprost 0.01%/brimonidine 0.15%/timolol 0.5% ophthalmic solution provides superior intraocular pressure (IOP)-lowering effects compared with a dual fixed combination of brimonidine 0.2%/timolol 0.5% in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT), according to the results of a phase III study.
The selective neurokinin 3 receptor antagonist fezolinetant induces rapid reductions in moderate-to-severe menopausal vasomotor symptoms (VMS) with a tolerable safety profile, according to the results of a phase IIb trial.
Patients with mild-to-moderate chronic kidney disease (CKD) may benefit from folic acid treatment, which helps reduce the likelihood of CKD progression, especially among those with high vitamin B12 levels, as shown in a study.
The allosteric inhibitor asciminib shows clinical activity in heavily pretreated patients with chronic myeloid leukaemia who have failed or cannot tolerate tyrosine kinase inhibitors, including those who do not respond to ponatinib and harbour a T315I mutation, according to the results of a phase I dose-escalation study.
A recent genome-wide association study (GWAS) performed by investigators from the Chinese University of Hong Kong (CUHK) has found potential new indications for existing drugs for the treatment of various psychiatric disorders.
The lower 0.25 mg/kg dose of the thrombolytic tenecteplase may be sufficient for reperfusion of blocked vessels prior to thrombectomy in patients with ischaemic stroke due to large-vessel occlusion compared with the 0.4 mg/kg dose, according to the EXTEND-IA TNK* Part 2 study presented at the ISC 2020 Meeting.
The eicosapeptide nerinetide did not improve outcomes in patients with large vessel occlusion-related acute ischaemic stroke who underwent endovascular thrombectomy (EVT). However, patients not treated with alteplase appeared to derive some benefit, results from the multinational ESCAPE-NA1* trial showed.