FDA’s 528-page rule snatches authority over tests that are developed, manufactured and performed by labs. Doctors prescribe such tests to identify prenatal genetic abnormalities, predict ...
On March 21, the FDA posted a summary on its website detailing the changes and classified the move as the “most serious type ...
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A proposal to ban formaldehyde in hair-straightening products that was scheduled to take place in April has not been released by the Food and Drug Administration, disregarding the agency’s own ...
Alert FDA OKs Ivosidenib for IDH1-mutated Myelodysplastic Syndromes The FDA approval was based on a small study, in which 38.9% of patients with relapsed or refractory disease went into complete ...
The head of the U.S. Food and Drug Administration (FDA), Dr. Robert Califf, pushed lawmakers on Thursday to pass a bill that would mandate that food manufacturers perform testing for lead in their ...
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Heart pumps recalled after reports of 14 deaths: FDA(NEXSTAR) — The Food and Drug Administration (FDA) announced Monday that two heart pump products are being recalled after reports of 14 deaths and hundreds of injuries were associated with the ...
Jamie Raskin, D-Md., ranking member of the committee, asked the FDA what it plans to do regarding many products, including lead-contaminated cinnamon applesauce pouches that caused many children ...
A California-based company has issued a warning over its toddler formula on Thursday after the U.S. Food and Drug Administration (FDA) said it may be unsafe for babies. Sammy's Milk of Newport ...
The FDA has flagged two areas that require additional review and said Supernus' application was not ready for approval in its present form, the company said. The regulator in 2022 refused to ...
The FDA has declined to approve Abeona Therapeutics' (NASDAQ:ABEO) therapy pz-cel, stating that it needs additional Chemistry Manufacturing and Controls information. The biotech company said in a ...
(RTTNews) - Roche (RHHBY) announced the FDA has approved Alecensa for adjuvant treatment following tumour resection for patients with anaplastic lymphoma kinase-positive non-small cell lung cancer.
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