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FDA flags safety concerns related to GSK's blood cancer drug

FDA staff flags eye safety risks for GSK's blood cancer drug
The U.S. Food and Drug Administration's staff reviewers on Tuesday raised safety concerns that GSK's blood cancer drug Blenrep, when used in combination with other treatments, may cause eye damage in patients.
FDA staff raises eye damage concerns for GSK's blood cancer drug
FDA to review myeloma drug after mixed trial data, eye safety concerns
The FDA is reevaluating GlaxoSmithKline’s blood cancer drug Blenrep following mixed results from two phase 3 trials and mounting concerns about eye-related side effects and dosing. The agency is meeting with its Oncologic Drugs Advisory Committee July 17 to discuss whether the drug’s proposed doses are appropriate given the high rates of ocular toxicity seen
FDA questions safety of GSK’s multiple myeloma drug
Ahead of an advisory committee meeting Thursday focused on GSK’s multiple myeloma drug Blenrep, the FDA pointed to concerns about the high rates of eye issues that have accompanied the use of the medicine and questioned the proposed dose.
US FDA Reviewers Highlight Safety Concerns With GSK’s Investigational Cancer Drug: Retail’s On The Fence
FDA reviewers said in briefing documents that the benefit-risk profile of the drug for the treatment of multiple myeloma “remains unclear.”
FDA flags safety concerns related to GSK’s blood cancer drug ahead of AdCom meeting
In briefing documents released ahead of an Advisory Committee meeting this week, FDA staffers cited safety risks related to a combination regimen involving GSK’s (NYSE:GSK) blood cancer drug Blenrep on Tuesday.
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FDA continuing talks about shifting food inspection to states
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Thousands laid off from NIH, FDA and CDC after Supreme Court decision
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Natural Remedy Dos and Don’ts for Multiple Sclerosis
Some vitamins and herbal supplements may help to relieve MS symptoms, but others are ineffective and might even be harmful. Learn which is which.
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FDA wants industry to suggest how to better use recalls for food safety
The Food and Drug Administration is calling on industry to provide input on how to better institute recalls, particularly for food for infants. In a ...
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Food and Drug Administration news - Today’s latest updates
The U.S. Food and Drug Administration approved the first over-the-counter birth control pill , allowing Americans to buy Opill, a daily oral contraceptive, without a prescription. Jul 13, 2023 ...
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Food and Drug Administration advisers are reviewing the Alzheimer's ...
Food and Drug Administration advisers are reviewing the Alzheimer's drug Donanemab FDA advisers are set to review an Alzheimer's drug found to slow the disease's progress in patients in the ...
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Plastic bits prompt YoCrunch yogurt recall
Sharp plastic pieces found in mix-in dome. The Food and Drug Administration and Danone are working to remove the product.
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Lee Yeon-bok's Rice Soup and Food and Drug Administration's Suspension and Recovery…Nonconformity with bacterial and E. coli standards
Lee Yeon-bok Rice Soup' was decided by the Ministry of Food and Drug Safety to withdraw the suspension of sales. The Ministry ...