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Original New Drug Application Approvals by US FDA (16-31 January 2025)

04 Feb 2025

New drug applications approved by US FDA as of 16-31 January 2025 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 (16-31 January 2025)

04 Feb 2025

Experimental HPV vaccine shrinks high-grade precancerous cervical lesions

02 Feb 2025 bởi

A novel vaccine that targets HPV type 16 (HPV16) has shown clinical activity against HPV16-positive cervical intraepithelial neoplasia grade 3 (CIN3) in a phase II trial, substantially reducing lesion size.

Experimental HPV vaccine shrinks high-grade precancerous cervical lesions

02 Feb 2025

Abnormal body weight in adolescence a risk factor for infertility in Asian women

02 Feb 2025

Underweight or obesity during adolescence may contribute to unexplained infertility later in life, as suggested in a large study involving Japanese women.

Abnormal body weight in adolescence a risk factor for infertility in Asian women

02 Feb 2025

Chamomile helps with menopausal symptoms

30 Jan 2025

Herbal intervention with Matricaria chamomilla, known as chamomile, appears to alleviate menopausal symptoms, as shown in the results of a triple-blind clinical trial.

Chamomile helps with menopausal symptoms

30 Jan 2025

Early menarche predicts hypertension in premenopausal women

28 Jan 2025

Early menarche is significantly associated with a higher chance of developing hypertension, specifically in women of reproductive age, suggests a study.

Early menarche predicts hypertension in premenopausal women

28 Jan 2025

Study finds DNA methylation profile for early breast cancer detection

28 Jan 2025 bởi

Researchers from Singapore have found a whole blood-based DNA methylation biomarker profile that effectively distinguishes breast cancer patients from healthy controls.

Study finds DNA methylation profile for early breast cancer detection

28 Jan 2025

CV events during pregnancy up risk of preterm birth, SGA

26 Jan 2025

Cardiovascular (CV) events during pregnancy appear to moderately increase the risk of adverse pregnancy outcomes (APOs), such as preterm birth, small for gestational age (SGA), or both, reports a recent study.

CV events during pregnancy up risk of preterm birth, SGA

26 Jan 2025

Postexposure doxycycline brings down STI rates among people on PrEP

24 Jan 2025 bởi

Individuals already taking pre-exposure prophylaxis (PrEP) for HIV prevention saw sharp declines in chlamydia and syphilis cases, as well as a moderate reduction in urethral and rectal gonorrhoea, when they also took doxycycline after potential exposure (doxyPEP).

Postexposure doxycycline brings down STI rates among people on PrEP

24 Jan 2025

In utero Zika exposure ups neurodevelopmental delay risk in early childhood

24 Jan 2025

Contraction of Zika virus infection during pregnancy may put the offspring at risk of neurodevelopmental delay in early childhood, as shown in a study.

In utero Zika exposure ups neurodevelopmental delay risk in early childhood

24 Jan 2025

No major pregnancy complications seen after fibroid ablation

23 Jan 2025

For pregnancies occurring after transvaginal radiofrequency ablation of leiomyomas, the outcomes appear to be similar to pregnancies in the general population, with no reports of uterine rupture, placental abruption, or foetal growth restriction, according to a study.

No major pregnancy complications seen after fibroid ablation

23 Jan 2025

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Original New Drug Application Approvals by US FDA (16-31 January 2025)

Original New Drug Application Approvals by US FDA (16-31 January 2025)

Experimental HPV vaccine shrinks high-grade precancerous cervical lesions

Experimental HPV vaccine shrinks high-grade precancerous cervical lesions

Abnormal body weight in adolescence a risk factor for infertility in Asian women

Abnormal body weight in adolescence a risk factor for infertility in Asian women

Chamomile helps with menopausal symptoms

Chamomile helps with menopausal symptoms

Early menarche predicts hypertension in premenopausal women

Early menarche predicts hypertension in premenopausal women

Study finds DNA methylation profile for early breast cancer detection

Study finds DNA methylation profile for early breast cancer detection

CV events during pregnancy up risk of preterm birth, SGA

CV events during pregnancy up risk of preterm birth, SGA

Postexposure doxycycline brings down STI rates among people on PrEP

Postexposure doxycycline brings down STI rates among people on PrEP

In utero Zika exposure ups neurodevelopmental delay risk in early childhood

In utero Zika exposure ups neurodevelopmental delay risk in early childhood

No major pregnancy complications seen after fibroid ablation

No major pregnancy complications seen after fibroid ablation