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November 3, 2022

Activities Report of the Generic Drugs Program | GDUFA II Quarterly Performance

In section VI(C)(2) of the Generic Drug User Fee Amendments Reauthorization for Fiscal Years 2018-2022(GDUFA II Commitment Letter), FDA committed to publishing quarterly metrics on its […]
November 3, 2022

Single Dose of Psilocybin for Major Depression Tied to Short-Term Remission Single Dose of Psilocybin for Major Depression Tied to Short-Term Remission

A single 25 mg dose of synthetic psilocybin in combination with psychotherapy appears to effectively ease symptoms of treatment-resistant depression (TRD) — at least in the […]
November 3, 2022

Olaparib Plus RT Well Tolerated in Triple-Negative Breast Cancer Olaparib Plus RT Well Tolerated in Triple-Negative Breast Cancer

Results from an early-phase trial conducted in patients with triple-negative breast cancer (TNBC) show that the combination of olaparib and radiotherapy was well tolerated. Olaparib, a […]
November 3, 2022

STEP TEENS: Semaglutide ‘Gives Hope’ to Adolescents With Obesity STEP TEENS: Semaglutide ‘Gives Hope’ to Adolescents With Obesity

Attendees at ObesityWeek® 2022 listened with much excitement to the results of the STEP TEENS phase 3 trial of once-weekly subcutaneous semaglutide 2.4 mg (Wegovy) in adolescents […]
November 3, 2022

Genital HSV Shedding Declines Rapidly in First Year Post Infection Genital HSV Shedding Declines Rapidly in First Year Post Infection

Shedding of genital herpes simplex virus was frequent soon after first-time infection but declined significantly during the first year, based on data from 82 individuals. Genital […]
November 3, 2022

Monkeypox Still a Public Health Emergency, According to Federal Officials

The HHS renewed its public health emergency declaration for monkeypox. Over 1 million people have now been vaccinated against the disease. Shortages of monkeypox vaccines and […]
November 3, 2022

Working Out in the Afternoon or Evening May Help Control Blood Sugar

A new study published this week found working out in the afternoon and evening may help control blood sugar. Researchers found that time spent doing moderate […]
November 3, 2022

How Higher Intensity Exercise Can Improve Your Heart Health

A new study found that increasing brisk physical activity may help significantly decrease the risk of cardiovascular disease. Brisk activity (such as running or speedwalking) may […]
November 2, 2022

FDA Puts REMS Requirements on Hold to Ensure Continuity of Care FDA Puts REMS Requirements on Hold to Ensure Continuity of Care

To ensure continuity of care for patients taking clozapine, the US Food and Drug Administration (FDA) will temporarily exercise “enforcement discretion” with respect to certain clozapine […]
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