October 26, 2021

FDA approves expanded indication of Biktarvy for treatment of HIV-1 in pediatric populations – Gilead Sciences

Gilead Sciences, Inc. announced the FDA approved a new low-dose tablet dosage form of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy. The approval of this supplemental New Drug Application (sNDA) expands the indication for Biktarvy […]

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October 25, 2021

Phase III monarchE trial of Verzenio in breast cancer published in Annals of Oncology – Eli Lilly

Eli Lilly announced updated data from the positive Phase III monarchE trial evaluating the investigational use of Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, high risk early breast cancer (EBC). As previously published in the Journal of Clinical Oncology, monarchE met its […]

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October 24, 2021

Janssen submits application seeking FDA approval of Stelara for the treatment of pediatric patients with juvenile psoriatic arthritis

The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA seeking expanded approval of Stelara (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA). The filing is supported by extrapolation of data from nine studies across both adult trials in active PsA and […]

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October 23, 2021

Oyster Point Pharma announces FDA approval of Tyrvaya nasal spray for the treatment of the signs and symptoms of dry eye disease

Oyster Point Pharma, Inc. announced that the FDA has approved Tyrvaya (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease. Tyrvaya Nasal Spray is the first and only nasal spray approved for the treatment of dry eye disease. Tyrvaya Nasal Spray is believed to bind to cholinergic receptors to activate the […]

admin Health 0 2 min read
October 22, 2021

Menopausal hormone therapy not linked to dementia onset

Menopausal hormone therapy (MHT — also known as hormone replacement therapy, HRT) does not appear to increase the risk of dementia onset, researchers reported on Sept. 29, 2021 in the BMJ/British Medical Journal. “We are happy to be able to report findings that will reassure women needing menopausal hormone therapy and facilitate conversations between doctors and patients about the safest […]

admin Health 0 1 min read

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