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A Popular Breakfast Brand’s Recall Has Been Updated To the FDA’s Highest Risk Level
There are two noteworthy updates from a notice issued late this week on what the FDA says could cause serious illness or ...
JD Supra2d
FDA Publishes Rule Updating ‘Healthy’ Nutrient Content Claim
On December 27, 2024, the US Food and Drug Administration (FDA) published its final rule to update the definition for “healthy” claims on food ...
FiercePharma1d
Astellas' eye med Izervay lands key FDA label update, amping up market battle with Apellis rival
In the face of tough competition from Apellis and a recent setback with prescribers, Astellas’ geographic atrophy (GA) med ...
Cookies Recall Update as FDA Sets Risk Level
The U.S. Food and Drug Administration (FDA) has given its second most serious risk level, Class II, to a product from D.
UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLI™ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...
JD Supra1d
Say Goodbye to the Red Dye: Legal Implications Following the FDA’s Recent Ban
On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use ...
Nut Recall Update for 8 States As FDA Sets Risk Level
A pecan nut product that was recalled due to undeclared walnuts has been given a Class II classification by the food agency.
PharmaTher Provides Update on FDA New Drug Application for Ketamine
PharmaTher expects to submit the MINOR AMENDMENT to the CRL by end-February 2025 and expects a new approval date for a Q2-2025 FDA approval of ketamineTORONTO, Feb. 12, 2025 (GLOBE NEWSWIRE) -- ...
Food Allergy Research & Education7d
Update to FDA Guidance for Food Allergen Labeling
Changes to the FDA labeling guidance in support of FALCPA include alterations to the definitions of “major” food allergens ...
More than 2M doughnut products recalled nationwide over listeria risk: FDA
The Food and Drug Administration has classified a recall of 60 different doughnut products to its second-highest level, the agency announced earlier this week in an update to its website.
Cure Today3d
An Expert Breaks Down What DPD Is and Labeling Updates From The FDA
Dr. Gabriel A. Brooks discusses the recent FDA product labeling update for Xeloda and 5-FU which aims to highlight risks associated with DPD deficiency.
Cure Today4d
Breaking Down the FDA Labeling Update of Xeloda and 5-FU in Cancer Care
The FDA has updated the product labeling for Xeloda and 5-FU to highlight the risks associated with dihydropyrimidine ...