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Month: September 2019

Drug Trials Snapshots: IBSRELA | FDA

September 27, 2019 Blogger

IBSRELA is a treatment for Irritable bowel syndrome with constipation The disease has two variants, with diarrhea and with constipation…

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Posted in: Health Technology Filed under: approvals, pdufa

Impact Story: Regulatory Science is Strengthening U.S. Drug Product Manufacturing | FDA

September 26, 2019 Blogger

FDA CDER is advancing manufacturing science to develop quicker, more reliable ways to make drugs and drug components. — Read…

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Posted in: Health Technology Filed under: FDA, technology

Molecular basis of dengue virus serotype 2 morphological switch from 29°C to 37°C

September 22, 2019 Blogger

Molecular basis of dengue virus serotype 2 morphological switch from 29°C to 37°C — Read on journals.plos.org/plospathogens/article

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Posted in: Health Technology Filed under: fixed dose combination, pdufa

DAURISMO for Acute Myeloid Leukemia

Blogger

On November 2018, the FDA approved Pfizer’s glasdegib (Daurismo) for the treatment of newly diagnosed acute myeloid leukemia (AML) in…

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Posted in: Health Technology Filed under: approvals, FDA, pdufa

NIH to investigate minor cannabinoids and terpenes for potential pain-relieving properties | National Institutes of Health (NIH)

September 21, 2019 Blogger

Despite a lack of robust evidence, cannabinoids—such as CBD—are often assumed to be safe and effective. — Read on www.nih.gov/news-events/news-releases/nih-investigate-minor-cannabinoids-terpenes-potential-pain-relieving-properties

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Posted in: Health Technology Filed under: FDA, fixed dose combination

FDA updates list of inquiries from prospective generic drug applicants about RLD access

September 19, 2019 Blogger

FDA updates list of inquiries from prospective generic drug applicants about RLD access — Read on s2027422842.t.en25.com/e/es

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Posted in: RLD Filed under: gdufa, RLD

Mayo researchers demonstrate senescent cell burden is reduced in humans by senolytic drugs – Mayo Clinic News Network

Blogger

Mayo researchers demonstrate senescent cell burden is reduced in humans by senolytic drugs — Read on newsnetwork.mayoclinic.org/discussion/mayo-researchers-demonstrate-senescent-cell-burden-is-reduced-in-humans-by-senolytic-drugs/

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Posted in: Health Technology Filed under: FDA, fixed dose combination, pdufa

Study quantifies impact of NIH-sponsored trials on clinical cancer care | National Institutes of Health (NIH)

September 18, 2019 Blogger

Researchers found trials add value regardless of whether findings were positive or negative. — Read on www.nih.gov/news-events/news-releases/study-quantifies-impact-nih-sponsored-trials-clinical-cancer-care Great Article!

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Posted in: Health Technology Filed under: FDA

FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma | FDA

September 17, 2019 Blogger

Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project,…

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Posted in: Health Technology Filed under: approvals, pdufa, technology

Statement alerting patients and health care professionals of NDMA found in samples of ranitidine | FDA

September 14, 2019 Blogger

The U.S. Food and Drug Administration has learned that some ranitidine medicines, including some products commonly known as the brand-name…

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Posted in: Health Technology, Uncategorized Filed under: FDA

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