News

GSK seeks FDA nod for expanded use of RSV vaccine in adults
(Reuters) -British drugmaker GSK said on Monday it had submitted an application to the U.S. Food and Drug Administration to ...
Mushrooms are being recalled over Listeria fears in two separate FDA notices: Avoid these products
Needle mushrooms and other mushroom products are impacted by two separate recall notices from the Food and Drug ...
FDA issues highest risk warning after mushrooms recalled nationwide
The Class I recall status indicates that the product poses a risk of causing serious health consequences or death if consumed ...
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FDA declines to approve Ultragenyx gene therapy
In his first 100 days as commissioner of the Food and Drug Administration, Marty Makary has made a handful of splashy ...
Fierce Pharma1h
Ultragenyx takes another hit as FDA snubs AAV gene therapy over manufacturing issues
The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...
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FDA urges infant and children’s food brands to improve recall communications under Operation Stork Speed
FDA is urging manufacturers of infant formula, baby food and children’s nutrition products to sharpen their recall ...
FDA Issues Risk Warning as Apples Recalled in Four States
A recall of thousands of cases of fruits and vegetables has been issued due to potential fluid contamination—the ...
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FDA: Commissioner’s National Priority Voucher Program Aims to Streamline Some Drug Reviews
The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, ...
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A Turning Point: FDA and NIH Commit to Reducing Animal Testing
The Food and Drug Administration (FDA), in collaboration with the National Institutes of Health (NIH), hosted a workshop ...
US FDA declines to approve Ultragenyx's gene therapy for rare genetic disorder
The U.S. Food and Drug Administration has declined to approve Ultragenyx Pharmaceutical's experimental gene therapy to treat ...
San Francisco-based company gets FDA approval to produce plant-based salmon
One San Francisco-based company aims to find a sustainable alternative by creating plant-based salmon, and with its recent ...
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 ...