Tag: Food and Drug Administration (FDA)

Video

Video: How the FDA’s New Guidance Will Affect the Food Allergy...

What the guidance does, how it affects the food allergy community, and how we can help you during this time of uncertainty.
Dupixent

FDA Approves Dupixent® as First Biologic for Treatment of Children Aged...

Three-quarters of patients receiving Dupixent achieved at least a 75% improvement in overall disease, with an average improvement of approximately 80%.

The FDA’s Recent Guidance Has Made Ingredient Labeling Less Reliable. Here’s...

Our agreements with 130 food manufacturers ensures you have the latest information.
Advisory

The FDA Has Relaxed Labeling Requirements Under COVID-19. What it Means...

The FDA's rash action introduces new concerns for the food allergy community.
Vial + Syringe

Pending Litigation Shows Food Allergy Treatments in Development are Sometimes Overhyped

Drugs — sometimes touted as miracle treatments during development — don't necessarily pan out despite the hype.
Epinephrine Auto-Injector

Sporadic Shortages of Epinephrine Devices Continue

Though epinephrine is currently readily available, emergency devices from specific manufacturers are experiencing sporadic shortages.
EpiPen Malfunctions

FDA Warns of Possible Malfunctions for EpiPen, EpiPen Jr, and Mylan’s...

Devices may potentially have delayed injection or be prevented from properly injecting.
Viaskin-Patch-Delay

FDA Has Questions About Viaskin Peanut Efficacy, Delays Meeting with DBV...

The company warned the FDA's target date for their decision on approval could be delayed.
Palforzia Capsules with Logo

Aimmune Provides FDA Mandated Program for Patients Considering Treatment of Peanut...

The FDA seeks to mitigate risks associated with treatment by mandating a program that must be followed by patients, prescribers, pharmacies, and healthcare settings.
Viaskin-Patch

FDA Advisory Committee Meeting to Review Viaskin Peanut for the Treatment...

Next step in the approval process for the therapy scheduled for May 15, 2020.