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 ...
dvm3609d
Drug label is updated for pain management therapy
Librela (bedinvetmab injection) is a monthly injectable monoclonal antibody, for which real-world drug experience data has ...
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 ...
Here’s What the FDA Label on Your Personal Care Products Means
Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...
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.
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 ...
Forbes17d
Ozempic Approved By FDA For Kidney Disease—In Ultra-Popular Drug’s Latest Approval
The European Union’s health regulators said in December that Novo Nordisk could expand its label for Ozempic, citing the same study, saying the drug could include information about reducing the ...
Managed Healthcare Executive1d
FDA Approves Expanded Label for Izervay, No Dosing Duration Limit
The updated label allows physicians to prescribe Izervay without a limitation on duration for patients with geographic ...
JD Supra4d
FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU) Communications
FDA published a final version of its guidance document, “Communications From Firms to Health Care Providers Regarding ...
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 ...
Healio21h
FDA approves Evrysdi tablets for spinal muscular atrophy
The FDA has approved Evrysdi in tablet form for patients with spinal muscular atrophy aged 2 years and older who weigh more ...
Vertex Pharma Stock Surges After FDA Approves Non-Opioid Pain Drug
Analyst is bullish on Vertex Pharmaceuticals, citing FDA approval for JOURNAVX and strong earnings growth potential in 2025.