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Oriahnn is the new non-surgical treatment for heav
FDA
FDA Approves New Treatment Oriahnn for Heavy Menstrual Bleeding Associated with Uterine Fibroids
AbbVie won first-of-its-kind approval for a non-surgical treatment, Oriahnn, aimed at treating heavy menstrual bleeding due to uterine fibroids, a common non-cancerous tumor, in pre-menopausal women.
June 1, 2020
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2 min read
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Alex Keown
FDA
Genentech’s Tecentriq-Avastin Combo Approved for HCC, an Improvement on Standard of Care
Tecentriq is an anti-PD-L1 checkpoint inhibitor. Avastin binds to the VEGF protein, which plays a significant role in the development and maintenance of blood vessels by cancer cells.
June 1, 2020
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3 min read
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Mark Terry
IgorGolovniov/Shutterstock
Policy
FDA Action Alert: Foamix, Immunomedics and Merck
Although the U.S. FDA is very busy dealing with emergency use approvals for diagnostics and possible treatments for COVID-19, it is still evaluating and approving therapies for non-COVID-19 indications. Here’s a look at this week’s calendar.
May 29, 2020
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4 min read
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Mark Terry
FDA
FDA Approves Lilly’s Tauvid Imaging Agent to Help Diagnose Alzheimer’s Disease
Tauvid is the first and only approved diagnostic agent for imaging tau neurofibrillary tangles (NFTs) in the brain.
May 29, 2020
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3 min read
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Mark Terry
Drug Development
Biopharma Update on the Novel Coronavirus: June 1
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for June 1, 2020.
May 28, 2020
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3 min read
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BioSpace Editorial Staff
Drug Development
Biopharma Update on the Novel Coronavirus: May 29
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 29, 2020.
May 28, 2020
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2 min read
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BioSpace Editorial Staff
Policy
Biopharma Update on the Novel Coronavirus: May 28
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 28, 2020.
May 28, 2020
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6 min read
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BioSpace Editorial Staff
Policy
Recalls Could be Imminent After FDA Discovers Carcinogens in Popular Diabetes Drug
The tests revealed that some metformin products contained the presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the regulatory agency.
May 28, 2020
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2 min read
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Alex Keown
Business
What Masks Can and Can’t Do, and Why You Should Wear One
Michael Bell, M.D., deputy director of the Division of Healthcare Quality Promotion at the Centers for Disease Control, teamed up with the Pandemic Action Network to help answer such questions and combat misinformation.
May 27, 2020
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4 min read
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Gail Dutton
Policy
Biopharma Update on the Novel Coronavirus: May 27
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for May 27, 2020.
May 27, 2020
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4 min read
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BioSpace Editorial Staff
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PRESS RELEASES
Policy
VA Rates 70 Percent of its Nursing Homes as Failures
November 14, 2018
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2 min read
Policy
Advisory - “Vita-X Revitalizing Capsules” for men may pose serious health risks
November 14, 2018
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1 min read
Policy
The governments of Canada and Saskatchewan improve access to treatment for people with substance use disorders
November 13, 2018
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3 min read
Policy
FDA warns StemGenex Biologic Laboratories LLC of illegally marketing an unapproved cellular product manufactured in a facility with significant manufacturing violations, putting patients at risk
November 13, 2018
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4 min read
Policy
Valens Receives Updated Health Canada License, Permits B2B Sales
November 12, 2018
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3 min read
Policy
One Step Closer to Being Federally Recognized to Accept Medicare / Medicaid and Tricare
November 12, 2018
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3 min read
Policy
FDA seizes food and medical products held under insanitary conditions at an Arkansas grocery warehouse
November 9, 2018
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2 min read
Policy
Notice to the media - The Governments of Canada and Saskatchewan will announce new measures to increase access to treatment for substance use disorder
November 9, 2018
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1 min read
Policy
Response to HHS Secretary Azar’s comments on a radiation oncology alternative payment model
November 8, 2018
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2 min read
Policy
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program
November 8, 2018
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7 min read
Policy
New York Passes Living Donor Protection Act
November 8, 2018
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2 min read
Policy
Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, on approval of OTC Primatene Mist to treat mild asthma
November 8, 2018
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6 min read
Policy
Hemopure® to be evaluated in groundbreaking clinical study of trauma patients in the prehospital setting, sponsored by the United States Department of Defense, and coordinated by Stellenbosch University
November 8, 2018
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3 min read
Policy
Advisory - Several store-brand pain or sinus relief tablets recalled because consumers may be unable to access important safety information
November 7, 2018
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2 min read
Policy
Luntz Poll: 81% Of Voters Oppose Taxing Employer-Provided Health Insurance
November 7, 2018
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2 min read
Policy
MassRoots Reviewing Missouri, Utah and Michigan Expansion, Following Successful Cannabis Ballot Initiatives
November 7, 2018
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4 min read
Policy
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s effort to make more robust use of mandatory recall authority to quickly remove unsafe foods from the market
November 5, 2018
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5 min read
Policy
Consumer Product Update - Health Canada identifies labelling concerns with certain wood finishing products
November 5, 2018
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3 min read
Policy
Voters Beware of Medicare-for-All Sabotage, Advises the Association of American Physicians and Surgeons (AAPS)
November 3, 2018
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2 min read
Business
Canada joins global partners in support of agriculture innovation and trade
November 2, 2018
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3 min read
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