News & Updates

New drug applications approved by US FDA as of 01 - 15 December 2022 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.

Lenadogene nolparvovec is well tolerated among patients with Leber hereditary optic neuropathy, being associated with mostly mild ocular side effects that can be resolved with conventional ophthalmologic treatments, according to the results of the LHON study.

The three-drug regimen consisting of topotecan, paclitaxel, and bevacizumab prolongs progression-free survival in women with recurrent high-grade neuroendocrine carcinoma of the cervix, as shown in a study.

Priapism, a debilitating condition that affects sexual function, predisposes men to greater cardiovascular and cerebrovascular events in the years following this penile condition, reveals a recent study.

IV sotalol administered rapidly as a loading dose to initiate oral sotalol therapy is feasible and safe for rhythm control in individuals with atrial fibrillation (AF), the DASH-AF study finds.

Interventions that consist of mindfulness training, exercise, or both do not seem to produce any improvements in episodic memory or executive function at 6 months among older adults with subjective cognitive concerns, according to a study.