FDA approves leucovorin for rare genetic condition

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FDA approves new use of synthetic vitamin B9 — but not for autism symptoms
The FDA announced a new approved use for the drug leucovorin, which Trump has touted as a treatment for autism. But the approval is for cerebral folate deficiency.

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FDA approves leucovorin for rare genetic condition, but not for autism
US FDA approves leucovorin for ultra- rare genetic disorder causing autism-like symptoms

FDA, Novo Nordisk

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Novo Nordisk receives FDA warning linked to US inspection in 2025
COPENHAGEN, March 10 (Reuters) - Novo Nordisk said on Tuesday it had received a warning letter from the U.S. Food and Drug Administration regarding an inspection at the Danish drugmaker's site in Plainsboro,

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STAT · 58m
Novo Nordisk is warned by the FDA for failing to report potential side effects tied to GLP-1 drugs
Fierce Pharma · 8h
Novo Nordisk's US headquarters under fire in latest FDA warning letter

FDA, oysters and Manila clams

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Seafood sold in NY recalled for possible norovirus contamination: FDA
Restaurant and food retailers across the United States are being warned of a potential norovirus contamination in seafood that was harvested between Feb. 13 and March 3. Sometimes

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Clams, raw oysters recalled over possible norovirus contamination across 9 states: FDA
Oysters and clams in 9 states could be contaminated with norovirus, FDA warns

FDA warns Novo over unreported potential Ozempic side effects, deaths

Novo Nordisk A/S got a warning letter from the US Food and Drug Administration for not reporting all suspected side effects in patients who took its blockbuster diabetes drug Ozempic.

FDA vaccine head will step down in April after string of controversial decisions

The top vaccine and biologics drug official in the U.S. Food and Drug Administration will step down in April. The agency made ...

FDA finds little evidence that a drug touted by Trump can help people with autism

The Food and Drug Administation is approving a generic drug for a very rare genetic disorder, but not for autism.

FDA vaccine chief to leave the agency for a second time

The Food and Drug Administration’s vaccine chief, Dr. Vinay Prasad, will depart the agency next month, an FDA spokesperson ...

Coconut water recall update as FDA sets risk level

About 12,000 cases of C20 Coconut Water were recalled and later classified Class III by the FDA over incorrect packaging.

FDA backs away from RFK Jr.’s claims about drug’s promise for autism patients

Food and Drug Administration Commissioner Marty Makary said in September he was changing leucovorin’s label because it could help “hundreds of thousands” of children with the neurological condition.

Key US senator investigates FDA over rare-disease drug denials

A key US Republican senator said he’s launched an investigation into the Food and Drug Administration’s recent denials of ...

FDA proposes to ease testing rules to speed up biosimilar drug development

March 9 (Reuters) - The U.S. health regulator issued a draft guidance on Monday to help drugmakers develop cheaper versions ...