News & Updates

Original New Drug Application Approvals by US FDA (01 - 15 April 2021)

15 Apr 2021

New drug applications approved by US FDA as of 01-15 April 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 (01 - 15 April 2021)

15 Apr 2021

OSA common in women with breast, endometrial cancers

14 Apr 2021

Obstructive sleep apnoea (OSA) is common among postmenopausal women with breast cancer or endometrial cancer, a recent study has found.

OSA common in women with breast, endometrial cancers

14 Apr 2021

Progesterone injection may up risk of early-onset cancer in offspring

13 Apr 2021 by

Using 17α-hydroxyprogesterone caproate (17-OHPC) to treat habitual and threatened abortion in pregnant women poses an increased future risk of cancer among their children, according to a study.

Progesterone injection may up risk of early-onset cancer in offspring

13 Apr 2021

Vitamin D during pregnancy tied to birth weight, preterm birth risk

12 Apr 2021

The mean rate of change in plasma 25-hydroxyvitamin (25[OH]D) during pregnancy is predictive of birth weight z-scores and is associated with the risks for large for gestational age (LGA) and preterm birth, suggests a recent study.

Vitamin D during pregnancy tied to birth weight, preterm birth risk

12 Apr 2021

Pregravid BMI strongly predicts maternal, infant outcomes

12 Apr 2021

Prepregnancy body mass index (BMI) appears to more strongly influence pregnancy outcomes than maternal age, a recent China study has found.

Pregravid BMI strongly predicts maternal, infant outcomes

12 Apr 2021

Endometrial thickness does not dictate embryo transfer outcome

09 Apr 2021

The chances of a live birth following either fresh or frozen-thawed embryo transfer cycles cannot be predicted by endometrial thickness alone, according to a study.

Endometrial thickness does not dictate embryo transfer outcome

09 Apr 2021

Fezolinetant may reduce VMS frequency, improve QoL in postmenopausal women

07 Apr 2021 by

Postmenopausal women with moderate or severe vasomotor symptoms (VMS), such as hot flashes and/or night sweats, who received fezolinetant were more likely to experience reduced VMS frequency and better health-related quality of life (QoL) than those on placebo, according to the secondary analysis of VESTA* study.

Fezolinetant may reduce VMS frequency, improve QoL in postmenopausal women

07 Apr 2021

Prophylactic aspirin during pregnancy staves off pre-eclampsia risk

06 Apr 2021

Among pregnant women, early initiation of low-dose aspirin largely reduces the incidence of pre-eclampsia and related neonatal outcomes without increasing the risk of bleeding, according to a meta-analysis.

Prophylactic aspirin during pregnancy staves off pre-eclampsia risk

06 Apr 2021

Modified treat-to-target approach paves road to LDA, remission in RA during pregnancy

03 Apr 2021 by

Low disease activity (LDA) and remission in women with rheumatoid arthritis (RA) can be easily achieved during pregnancy with the help of a modified treat-to-target (T2T) approach that incorporates the use of tumour necrosis factor inhibitors (TNFIs), as shown in the PreCARA* study.

Modified treat-to-target approach paves road to LDA, remission in RA during pregnancy

03 Apr 2021

Extended duration dapivirine vaginal ring shows promise for HIV prevention

02 Apr 2021 by

The use of a 90-day extended duration vaginal ring containing 100 or 200 mg of the antiretroviral drug dapivirine appeared safe, effective, and acceptable among HIV-negative women, according to results of a phase I trial presented at CROI 2021.

Extended duration dapivirine vaginal ring shows promise for HIV prevention

02 Apr 2021

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Original New Drug Application Approvals by US FDA (01 - 15 April 2021)

Original New Drug Application Approvals by US FDA (01 - 15 April 2021)

OSA common in women with breast, endometrial cancers

OSA common in women with breast, endometrial cancers

Progesterone injection may up risk of early-onset cancer in offspring

Progesterone injection may up risk of early-onset cancer in offspring

Vitamin D during pregnancy tied to birth weight, preterm birth risk

Vitamin D during pregnancy tied to birth weight, preterm birth risk

Pregravid BMI strongly predicts maternal, infant outcomes

Pregravid BMI strongly predicts maternal, infant outcomes

Endometrial thickness does not dictate embryo transfer outcome

Endometrial thickness does not dictate embryo transfer outcome

Fezolinetant may reduce VMS frequency, improve QoL in postmenopausal women

Fezolinetant may reduce VMS frequency, improve QoL in postmenopausal women

Prophylactic aspirin during pregnancy staves off pre-eclampsia risk

Prophylactic aspirin during pregnancy staves off pre-eclampsia risk

Modified treat-to-target approach paves road to LDA, remission in RA during pregnancy

Modified treat-to-target approach paves road to LDA, remission in RA during pregnancy

Extended duration dapivirine vaginal ring shows promise for HIV prevention

Extended duration dapivirine vaginal ring shows promise for HIV prevention