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Category: Health Technology

FDA Announces Availability of Draft Guidance – Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Software

October 28, 2019 Blogger

FDA Announces Availability of Draft Guidance – Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics…

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

FDA approves new breakthrough therapy for cystic fibrosis | FDA

October 21, 2019 Blogger

FDA approves breakthrough therapy Trikafta for patients 12 and older with cystic fibrosis who have at least one F508del mutation…

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

Blocking Inflammatory Pathway May Stop Brain Metastasis from Melanoma

October 20, 2019 Blogger

Melanoma brain metastasis occurs when tumor cells hijack an inflammatory pathway in the brain and blocking this pathway could prevent…

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Posted in: Health Technology Filed under: FDA, technology

Ceritinib Response Seen in Study of Brain Metastases in ALK-Positive NSCLC

October 12, 2019 Blogger

“The efficacy of ceritinib was evaluated in patients who have ALK-positive non-small cell lung cancer with active brain metastases.” —…

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Posted in: Health Technology Filed under: FDA, pdufa

Treating Pancreatic Cancer by Altering the Tumor Microbiome – National Cancer Institute

October 1, 2019 Blogger

In people with pancreatic cancer, the composition of their tumor microbiome might predict how long they live, according to a…

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Posted in: Health Technology Filed under: fixed dose combination

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

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