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FDA staff raises eye damage concerns 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 ...
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New UAB-developed gene therapy for ALS receives orphan drug designation
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to a new gene therapy for Amyotrophic Lateral ...
FDA Announces Massive Recall of Popular Produce in 4 States and DC
The U.S. Food and Drug Administration announced a massive recall of 30 different kinds of produce over possible contamination ...
FDA approves Kerendia for heart failure with ejection fraction of 40% or higher
Following priority review, the U.S. Food and Drug Administration approved Bayer's Kerendia (finerenone) for the treatment of ...
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FDA Commissioner: ‘We want to focus on food’
“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed ...
FDA to consider drug affordability when granting new vouchers to speed up approvals, Makary says
It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...
FDA approves shot that protects dogs from fleas and ticks for 8-12 months
The U.S. Food and Drug Administration has approved Bravecto Quantum, a new shot that protects dogs six months or older ...
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Pharmalittle: We’re reading about a FDA offer on drug reviews, a Moderna Covid approval, and more
FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...