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Maintenance olaparib confers survival benefit for HRD+ ovarian cancer patients

19 Dec 2022 by

In the final overall survival (OS) analysis of the phase III PAOLA-1*/ENGOT-ov25 trial, the addition of olaparib to bevacizumab provided a survival benefit for women with newly diagnosed advanced ovarian cancer with HRD**-positive (HRD+) tumours.

19 Dec 2022

Original New Drug Application Approvals by US FDA (1 - 15 December 2022)

19 Dec 2022

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.

19 Dec 2022

Lenadogene nolparvovec safe in patients with Leber hereditary optic neuropathy

18 Dec 2022

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.

18 Dec 2022

Three-drug regimen shows promise in neuroendocrine carcinoma of the cervix

18 Dec 2022

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.

18 Dec 2022

One in eight adults experiences long COVID

18 Dec 2022 by

One in every eight individuals who has experienced COVID-19 may have persistent symptoms 3–5 months post-infection, according to an observational study from the Netherlands.

18 Dec 2022

Rapid IV sotalol loading feasible, safe for AF patients

18 Dec 2022 by

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.

18 Dec 2022

Study reinforces guideline to avoid prescribing EIASMs in glioma patients with epilepsy

17 Dec 2022

First-line monotherapy with levetiracetam appears to have a more favourable effectiveness than enzyme-inducing antiseizure medications (EIASMs) in glioma patients with epilepsy, owing to lower treatment failure for any reason and better tolerability, according to a study, which supports the current neuro-oncology recommendations to avoid EIASMs in this population.

17 Dec 2022

Novel topical dexamethasone formulation reduces inflammation, pain after cataract surgery

17 Dec 2022

OCS-01, a topical dexamethasone 1.5% in a novel formulation, appears to be safe and effective in the management of inflammation and pain following cataract surgery, a study has found.

17 Dec 2022

Stopping RAS inhibitors does not slow eGFR decline in advanced CKD

16 Dec 2022 by

In patients with advanced chronic kidney disease (CKD), discontinuing renin–angiotensin system (RAS) inhibitor therapy does not slow down decline in estimated glomerular filtration rate (eGFR), a recent trial showed.

16 Dec 2022

Sotorasib improves PFS over docetaxel in KRASG12C-mutated advanced NSCLC

15 Dec 2022 by

The first-in-class KRAS^G12C inhibitor sotorasib significantly improved progression-free survival (PFS) in patients with previously treated non-small cell lung cancer (NSCLC) with KRAS^G12C mutations, according to results of the phase III CodeBreaK 200 trial presented at ESMO 2022.

15 Dec 2022

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Maintenance olaparib confers survival benefit for HRD+ ovarian cancer patients

Original New Drug Application Approvals by US FDA (1 - 15 December 2022)

Lenadogene nolparvovec safe in patients with Leber hereditary optic neuropathy

Three-drug regimen shows promise in neuroendocrine carcinoma of the cervix

One in eight adults experiences long COVID

Rapid IV sotalol loading feasible, safe for AF patients

Study reinforces guideline to avoid prescribing EIASMs in glioma patients with epilepsy

Novel topical dexamethasone formulation reduces inflammation, pain after cataract surgery

Stopping RAS inhibitors does not slow eGFR decline in advanced CKD

Sotorasib improves PFS over docetaxel in KRASG12C-mutated advanced NSCLC