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Youth Vaping Down, But Still Popular: CDC
drugs.com
September 18, 2020
The number of U.S. youths who use e-cigarettes fell from 5.4 million in 2019 to 3.6 million this year -- but vaping remains a dangerous epidemic among children and teens, a new government report shows.
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Zydus Cadila gets tentative USFDA nod for empagliflozin and linagliptin tablets
expresspharma
September 18, 2020
They are oral diabetes medicines that help control blood sugar levels.
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GSK gets US FDA approval for Trelegy Ellipta to treat asthma, COPD
expresspharma
September 18, 2020
Trelegy is the first single inhaler triple therapy approved for the maintenance treatment of both asthma and COPD.
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FDA Clears IND Application for Vaxart Oral COVID-19 Vaccine
contractpharma
September 17, 2020
ecruitment for the Phase 1 clinical study is expected to start this month.
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Janssen Submits Light Chain Amyloidosis Treatment to FDA
americanpharmaceuticalreview
September 17, 2020
Halozyme Therapeutics announced its collaborator Janssen Biotech has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) ...
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Project ALS Granted FDA Orphan Drug Designation for Prosetin
americanpharmaceuticalreview
September 17, 2020
Project ALS announced the Food and Drug Administration (FDA) has granted orphan drug designation to prosetin for the treatment of ALS. Prosetin is an oral, brain penetrant MAP4 kinase inhibitor developed by scientists at Columbia University for the ...
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Blueprint Announces FDA Approval of GAVRETO for Metastatic Non-Small Cell Lung Cancer
americanpharmaceuticalreview
September 17, 2020
Blueprint Medicines announced the U.S. Food and Drug Administration (FDA) has approved GAVRETO™ (pralsetinib) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer ...
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FDA Releases COVID-19 Response At-A-Glance Summary
americanpharmaceuticalreview
September 17, 2020
The U.S. Food and Drug Administration (FDA), along with other federal, state, and local agencies and public health officials across the country, continues critical work to protect public health during the pandemic of COVID-19.
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FDA Approves GAVRETO for Metastatic Rearranged During Transfection Fusion-Positive NSCLC
americanpharmaceuticalreview
September 16, 2020
The U.S. Food and Drug Administration (FDA) approved GAVRETO (pralsetinib) for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
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US FDA denies approval to Mallinckrodt for Terlipressin to treat Hepatorenal Syndrome Type 1
expresspharma
September 16, 2020
The Complete Response Letter stated that, based on the available data, the agency cannot approve the terlipressin NDA in its current form and requires more information to support a positive risk-benefit profile for terlipressin for patients with HRS-1.