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FDA Pushes Label Change for Acetaminophen in Pregnancy, Approves Leucovorin Calcium for CFD
23 Sep 2025 04:17 GMT
… Folate Deficiency
In parallel, the FDA approved leucovorin calcium for CFD after … .1
Regarding CFD, although this approval has no direct impact on … of this content.
References
US Food and Drug Administration. FDA Responds to Evidence of Possible …
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FDA Fast-Tracks Treatment For Autism-Related Symptoms
23 Sep 2025 02:26 GMT
… .S. Food and Drug Administration (FDA) announced today it has initiated the process to approve leucovorin … : cerebral folate deficiency (CFD). This […]
FDA Fast-Tracks Treatment For Autism …
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Trump orders FDA warning on Tylenol during pregnancy amid autism concerns despite scientific evidence
23 Sep 2025 04:11 GMT
… 22, that the US Food and Drug Administration will notify physicians that acetaminophen … science and agree."
FDA approves leucovorin treatment for autistic childrenOz … children. The FDA is also restoring previously withdrawn approval of Wellcovorin, …
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FDA to warn doctors about Tylenol-Autism link, sparking medical backlash
23 Sep 2025 01:42 GMT
… inconclusive. Big picture view: The Food and Drug Administration (FDA) will begin notifying doctors to … the last decade and the Food and Drug Administration will immediately instruct doctors to … -Tylenol is the only drug approved for use during pregnancy. Ob …
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US regulator approves drug for autism treatment
23 Sep 2025 01:54 GMT
… United States (US) pharmaceutical regulator approved the drug leucovorin for the … Food and Drug Administration said in the US Federal Register that it had approved leucovorin …
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IBD 50's Tempus AI Pulls Back From Record High After Another FDA Clearance
23 Sep 2025 02:40 GMT
… gain Monday after the Food and Drug Administration cleared its new device … written statement. "This FDA clearance further demonstrates the promise … .
The company says the FDA's clearance solidifies …
Merck Snags A Key Approval Before Its Cash Cow Goes …
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Trump claims link between Tylenol and autism, warns against its use; do scientific studies approve of his assertions
23 Sep 2025 03:03 GMT
US President Donald Trump on Monday (September 22, 2025) linked the use of Tylenol during pregnancy to autism. He said that the US Food and Drug Administration will notify doctors that the use of Tylenol by women during pregnancy can be associated with a “ …
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FDA use of Real-World Evidence in Regulatory Decision Making
23 Sep 2025 03:56 GMT
… in pediatric populations. FDA approved safety labeling changes to … Initiative), April 18, 2024. FDA Labeling Change: Vedolizumab & … July. 3, 2013. FDA Approves Labeling Changes to Include Intestinal … trial used to approve Pradaxa. FDA issued a DSC …
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With new FDA nod in ulcerative colitis, J&J's Tremfya becomes 1st IL-23 med with IV and subQ options across IBD treatment
23 Sep 2025 02:33 GMT
… drug class.
Friday, the FDA approved a subcutaneous induction regimen … —won IV and subcutaneous approvals to treat adults with … a statement.
The newly approved self-administration format has … approved IV induction dose, Rubin added.
The FDA based its approval …
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FDA turns down Lundbeck, Otsuka's Rexulti in PTSD on lack of efficacy data
23 Sep 2025 02:33 GMT
… (PTSD) hopeful.
The FDA has issued a complete response … but could not currently approve it, citing a lack … their application, which the FDA accepted for review last … statistical significance.
Rexulti holds approvals in three other psychiatric indications …
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