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Original New Drug Application Approvals by US FDA (16-30 September 2021)

04 Oct 2021

New drug applications approved by US FDA as of 16 -30 September 2021 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.

Original New Drug Application Approvals by US FDA (16-30 September 2021)

04 Oct 2021

Cervical adenocarcinoma has good survival rates when caught, treated early

03 Oct 2021

Cervical adenocarcinoma has at least a 50 percent survival rate which can be further improved by early diagnosis and individualized and comprehensive treatment, a recent study has found.

Cervical adenocarcinoma has good survival rates when caught, treated early

03 Oct 2021

Pembro + chemo: ‘Practice-changing’ in advanced cervical cancer

29 Sep 2021 bởi

Adding pembrolizumab to chemotherapy with or without bevacizumab significantly extends overall survival (OS) by 8 months in women with recurrent, persistent or metastatic cervical cancer, according to the KEYNOTE-826 study presented at ESMO 2021.

Pembro + chemo: ‘Practice-changing’ in advanced cervical cancer

29 Sep 2021

Abnormal STE myocardial function prevalent in women with HELLP syndrome history

27 Sep 2021

The rate of abnormal speckle-tracking echocardiography (STE) myocardial function is high during the first years following a pregnancy complicated by haemolysis, elevated liver enzymes, and low platelets (HELLP) syndrome, regardless of whether there was concomitant pre-eclampsia (PE), reveals a study.

Abnormal STE myocardial function prevalent in women with HELLP syndrome history

27 Sep 2021

Diabetes ups glaucoma risk in postmenopausal women

23 Sep 2021

Among postmenopausal women, diabetes status is correlated with an increased risk of subsequent glaucoma, a recent Korea study has found.

Diabetes ups glaucoma risk in postmenopausal women

23 Sep 2021

Exercise during pregnancy tied to better lung function in babies

21 Sep 2021 bởi

Infants born to mothers who were inactive during pregnancy were more likely to have low lung function compared with those whose mothers were active while pregnant, according to the PreventADALL study presented at ERS 2021.

Exercise during pregnancy tied to better lung function in babies

21 Sep 2021

Lenvatinib-pembrolizumab improves OS, PFS in advanced endometrial carcinoma regardless of DNA MMR status

16 Sep 2021 bởi

The combination of lenvatinib and pembrolizumab improved progression-free survival (PFS) and overall survival (OS) compared with physician’s choice of treatment (TPC) among patients with advanced endometrial cancer with prior exposure to platinum-based therapy, regardless of DNA mismatch repair (MMR) status, according to results of a phase III study presented at IGCS 2021.

Lenvatinib-pembrolizumab improves OS, PFS in advanced endometrial carcinoma regardless of DNA MMR status

16 Sep 2021

Pre-eclampsia a risk factor for postpartum acute kidney injury

16 Sep 2021

Women with pre-eclampsia are at risk of developing acute kidney injury at 90 days or beyond after giving birth, according to a study.

Pre-eclampsia a risk factor for postpartum acute kidney injury

16 Sep 2021

Licogliflozin shows promise in polycystic ovary syndrome

15 Sep 2021

Dual sodium-glucose co-transporter 1/2 (SGLT1/2) inhibition with licogliflozin appears to produce reductions in hyperinsulinaemia and hyperandrogenaemia in women with polycystic ovary syndrome, as shown in a phase II study.

Licogliflozin shows promise in polycystic ovary syndrome

15 Sep 2021

Intensive follow-up does not improve survival in endometrial cancer

13 Sep 2021 bởi

Intensive follow-up for 5 years did not improve overall survival (OS) or relapse-free survival (RFS) in patients who have undergone surgical treatment for endometrial cancer, according to results of the TOTEM study presented at IGCS 2021.

Intensive follow-up does not improve survival in endometrial cancer

13 Sep 2021

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Original New Drug Application Approvals by US FDA (16-30 September 2021)

Original New Drug Application Approvals by US FDA (16-30 September 2021)

Cervical adenocarcinoma has good survival rates when caught, treated early

Cervical adenocarcinoma has good survival rates when caught, treated early

Pembro + chemo: ‘Practice-changing’ in advanced cervical cancer

Pembro + chemo: ‘Practice-changing’ in advanced cervical cancer

Abnormal STE myocardial function prevalent in women with HELLP syndrome history

Abnormal STE myocardial function prevalent in women with HELLP syndrome history

Diabetes ups glaucoma risk in postmenopausal women

Diabetes ups glaucoma risk in postmenopausal women

Exercise during pregnancy tied to better lung function in babies

Exercise during pregnancy tied to better lung function in babies

Lenvatinib-pembrolizumab improves OS, PFS in advanced endometrial carcinoma regardless of DNA MMR status

Lenvatinib-pembrolizumab improves OS, PFS in advanced endometrial carcinoma regardless of DNA MMR status

Pre-eclampsia a risk factor for postpartum acute kidney injury

Pre-eclampsia a risk factor for postpartum acute kidney injury

Licogliflozin shows promise in polycystic ovary syndrome

Licogliflozin shows promise in polycystic ovary syndrome

Intensive follow-up does not improve survival in endometrial cancer

Intensive follow-up does not improve survival in endometrial cancer