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FDA warns about safety of 'off-brand' versions of Ozempic, Wegovy
02 Jun 2023 15:35 GMT
My Clallam County - Washington State
… is permissible by the FDA. Wegovy is FDA-approved for weight loss … pharmacies. In May, the FDA told ABC News’ Good Morning … higher risk to patients than FDA-approved drugs because compounded … drugs do not undergo FDA premarket review for safety, …
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New FDA Guidance for Long-standing Deferral; HIV Changes
02 Jun 2023 14:45 GMT
DVIDS
… significant changes is that the FDA now recommends “...eliminating the … gender,” according to the FDA announcement. Instead, guidance would … HIV infection. Newly issued FDA guidance recommends a three- … This work, New FDA Guidance for Long-standing Deferral …
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Theratechnologies Receives FDA Agreement to Amended Trial Protocol for its Lead PDC Candidate Sudocetaxel Zendusortide
02 Jun 2023 16:15 GMT
GlobeNewswire, Inc.
… . Food and Drug Administration (FDA) has agreed to the Company … scientific advisory committee and the FDA to align on this updated … be found here, informed the FDA-approved amended protocol. On June … treat many cancers. The FDA granted Fast Track designation to …
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La FDA approuve la modification du protocole de l’essai de Theratechnologies portant sur son principal CPM expérimental, le sudocétaxel zendusortide
02 Jun 2023 16:15 GMT
GlobeNewswire, Inc.
… la Food and Drug Administration (FDA) des États-Unis a accepté … sommes très heureux que la FDA ait accepté nos plans visant … comité consultatif scientifique et la FDA pour nous entendre sur cette … traiter de nombreux cancers. La FDA des États-Unis a accordé …
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FDA issues warning to heart monitor manufacturer
02 Jun 2023 15:15 GMT
Becker's Hospital Review
The FDA issued a warning letter to … , but as of May the FDA was not satisfied. The agency … yet been released by the FDA. The warning does not restrict … work diligently to address the FDA's concerns."
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FDA approval sought for Vietnam-made ASF vaccine
02 Jun 2023 14:35 GMT
CNN Philippines
… the Food and Drug Administration (FDA) for the rollout of a … (CPR). A CPR from the FDA is needed to allow the … 's also Agriculture Secretary. FDA Spokesperson Job Aguzar said the …
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FDA to assist pharmacies with drugs in short supply
02 Jun 2023 15:40 GMT
Taipei Times
The Food and Drug Administration (FDA) on Friday said it would … respiratory conditions in China, the FDA said. Photo: Lin Hui-chin … , Taipei Times The FDA said it received a report …
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Potassium blood level home-monitoring device receives FDA fast track
02 Jun 2023 17:15 GMT
Medical Device Network
… Food and Drug Administration (FDA) has granted CardioRenal’s potassium … to be used with the FDA-cleared Tasso blood collection … to working closely with the FDA to start our clinical … 2023, the company received FDA breakthrough designation for its RenalGuard …
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Omniscient Announces FDA-Clearance of New MRI-based Functional Brain Analysis Technology
02 Jun 2023 14:00 GMT
GlobeNewswire, Inc.
FDA-cleared AI brain-mapping software, … the human brain, today announced FDA clearance of its new functional …
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FDA advises students against tobacco use
02 Jun 2023 15:51 GMT
Myjoyonline.com
… the Food and Drugs Authority (FDA) Thursday, June 1 engaged some … Public Relations Officer of the FDA, Mr Solomon Boni said the …
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Medicare Will Cover New Class of Alzheimer's Drugs if Fully Approved by FDA, With Limits
02 Jun 2023 14:04 GMT
HealthDay
… the change. "If the FDA grants traditional approval, CMS is … requirement for coverage” of an FDA-approved treatment. But the CMS …
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Ezra wins FDA approval for new AI tech to improve brain imaging
02 Jun 2023 17:16 GMT
Medical Device Network
… US Food and Drug Administration (FDA) for its new artificial intelligence … and precise image. The latest FDA clearance marks a significant milestone …
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von Willebrand disease treatment gets FDA orphan drug designation
02 Jun 2023 15:42 GMT
Labiotech
… .S. Food and Drug Administration (FDA) has granted Vega Therapeutics, Inc …
- FDA to begin construction near Tyler Perry Studios, despite objection 02 Jun 2023 17:08 GMT The Business Journals
- Medicare to provide limited coverage of new Alzheimer's drugs upon FDA approval 02 Jun 2023 15:57 GMT United Press International (UPI)
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Morning Business Report: Most FDA approved Alzheimer’s medication will be covered by Medicare
02 Jun 2023 12:36 GMT
WMGT 41 - Georgia
FDA approved drugs for Alzheimer’s …
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FDA’s distorted priorities are costly
02 Jun 2023 11:58 GMT
Washington Examiner
… 15-year veteran of the FDA who evaluated drugs in the … , for many months. Among the FDA’s worst shortcomings is its … ’s unclear from where the FDA thinks it derives jurisdiction over … and better management at the FDA. I am not optimistic that …
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Hemogenyx Pharmaceuticals Shares Fall After FDA Puts Leukemia Treatment Application on Hold
02 Jun 2023 11:07 GMT
MarketWatch
By Elena Vardon Hemogenyx Pharmaceuticals shares slumped 28% on Friday after the company said its application for its acute myeloid leukemia treatment product candidate was put on clinical hold by the U.S. Food and Drug Administration pending more …
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Cigar trade group pushes back at FDA proposal to ban flavored cigars
02 Jun 2023 10:59 GMT
Fairfield County Business Journal - Connecticut
… .S. Food and Drug Administration (FDA) could have a deleterious impact … public health. In April the FDA proposed a prohibition on “all …
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Department of Agriculture seeks FDA nod on Vietnam-made ASF vaccine
02 Jun 2023 10:16 GMT
Balita Media Inc - California
… the Food and Drug Administration (FDA) to certify a Vietnam-made … have endorsed it to the FDA for the issuance of Certificate … official is hoping that the FDA will immediately issue the CPR …
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FDA Finalizes Stricter Guidance On Inorganic Arsenic Levels in Apple Juice
02 Jun 2023 10:13 GMT
Medical Daily
… . Food and Drug Administration (FDA) has implemented stricter guidelines regarding … show higher levels, the FDA may take action against the … this reason that the FDA hopes to encourage more … good manufacturing practices," the FDA explained. "As lower …
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Consumer Reports Challenges FDA’s ‘High’ Arsenic Limits in Apple Juice, Citing Health Risks to Children
02 Jun 2023 06:45 GMT
The Epoch Times
… cardiovascular and neurodevelopmental issues. The FDA acknowledges that completely eliminating arsenic … compared to adults. The FDA highlighted research indicating a potential … a mandatory requirement. Nevertheless, the FDA expects that this recommended level …
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US FDA approves Pfizer's Abrysvo vaccine for prevention of respiratory syncytial virus in older adults
02 Jun 2023 05:04 GMT
Pharmabiz.com
… Food and Drug Administration (FDA) has approved Abrysvo (respiratory … investigator. “Today’s FDA approval of Abrysvo recognizes … 2022, Pfizer announced the FDA granted Breakthrough Therapy Designation … Pfizer announced that the FDA had granted priority review …
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FDA adopts decade-old draft guidance for arsenic in apple juice
02 Jun 2023 05:01 GMT
Food Safety News
… would be criticized, the FDA’s announcement included what … inorganic arsenic,” according to the FDA’s final guidance document. … , which includes participation by FDA scientists, concluded that food … . “. . . recent research by FDA shows that the use of …
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Sedgwick releases Q1 U.S. product recall index report including FDA and USDA data
02 Jun 2023 05:01 GMT
Food Safety News
… more aggressive enforcement strategy. The FDA has outlined an ambitious list … also on notice from the FDA, which issued a constituent … the medical device industry, the FDA is focused on improving the … another main focus for the FDA, which has begun research …