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 ...
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 ...
Incyte: Q4 Earnings Outline Multiple Drug Launches In 2025
Incyte has a strong track record of revenue growth and a robust pipeline, targeting over 10 high-impact product launches by ...
GLP-1 Drugs Drive Growth for Eli Lilly. Is the Stock a Buy?
After pre-announcing that its full-year revenue would come in below its original guidance, Eli Lilly (NYSE: LLY) announced ...
U.S. FDA Approves Expanded Label For Astellas' IZERVAYTM (Avacincaptad Pegol Intravitreal Solution) For Geographic Atrophy
IZERVAY dosing approved beyond 12 monthsTOKYO, Feb. 12, 2025 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Ok ...
Supply Chain5d
U.S. Pharma Companies Weigh a Shift to North America — and Possibly the U.S. — for Drug Production
“Companies are realizing that investing stateside can provide more control and resilience to the drug supply chain,” says ...