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A magnetic system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy has been approved by the U.S. Food and Drug Administration.

FDA Approves Magnetic System for Guiding Lymph Node Biopsies

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Sentimag System uses magnetic detection to identify sentinel lymph nodes for surgical removal
The U.S. Food and Drug Administration has approved ribociclib in combination with an aromatase inhibitor as an initial endocrine-based therapy for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor-positive

FDA Grants First Approval for CA Drug Under New Pilot Programs

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Ribociclib approved in combo with AI as endocrine tx for HR-positive, HER2-negative advanced breast CA
Users of synthetic marijuana products and health care providers should be aware of the risk of bleeding associated with contamination of synthetic cannabinoid products with brodifacoum

FDA Warns Against Risks of Contaminated Synthetic Cannabis

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Risk of bleeding associated with contamination of synthetic marijuana products with brodifacoum
Tibsovo (ivosidenib) tablets have been approved by the U.S. Food and Drug Administration to treat relapsed or refractory acute myeloid leukemia among people with a defective IDH1 gene.

FDA Approves Tibsovo for Acute Myeloid Leukemia

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Approved for adults with relapsed or refractory acute myeloid leukemia who have IDH1 mutation
A new rule proposed by the U.S. Food and Drug Administration suggests that the type size on packaged foods sold in vending machines be at least 1.5 times the size of the net weight declaration on the front of the package.

FDA Proposes New Rule on Food Labeling in Vending Machines

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Revised rule suggests that type size on packaged food must be 1.5 times size of net weight declaration
Amid lawsuits and plummeting sales for its Essure birth control device

Bayer Stops U.S. Sale of Essure Birth Control Implant

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Problems with device include chronic pain and perforations of the uterus and fallopian tubes
Several drug products containing the active ingredient valsartan

FDA Recalls Drugs Containing Active Ingredient Valsartan

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All lots of non-expired products that contain valsartan supplied by Zhejiang Huahai being recalled
Pivotal trials supporting U.S. Food and Drug Administration approvals granted Breakthrough Therapy designation often lack randomization

Trials Supporting FDA Approval of Breakthrough Drugs Examined

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Pivotal trials supporting these approvals often lack randomization, double-blinding, control groups
Criminals are sending fake U.S. Food and Drug Administration warning letters to people who tried to buy medicines online or over the phone. The agency notes that it does not typically send warning letters to individuals

Fake FDA Warning Letters Being Sent to Consumers

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Letters accuse consumer of drug violations based on a review of their parcels and social media accounts
TPOXX (tecovirimat) has been approved by the U.S. Food and Drug Administration to treat smallpox.

FDA Approves First Drug to Treat Smallpox

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New treatment offers additional option should smallpox ever be used as a bioweapon