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Tag: Food and Drug Administration (FDA)

Surprised Baby

FDA Approves New Peanut Allergy Claim on Labels

Labels may soon claim that early introduction of peanuts may reduce the risk of infants developing peanut allergy.
Pfizer HQ

FDA Warns Pfizer’s Meridian over Handling of EpiPen Malfunctions

Company has 15 working days to respond to numerous FDA concerns.
Auvi-Q

FDA Grants Kaleo Priority Review Status for Auvi-Q Designed for Infants and Small Children

The new epinephrine auto-injector would feature a lower dose and shorter needle length suitable for smaller children.

Approval of Adamis Emergency Epinephrine Solution Expected Next Month

The market is anticipating FDA approval of a novel method of delivering emergency epinephrine.

Company Seeks to Remove the Allergist from Treating Food Allergy

AllergyEasy manufactures drops used in sublingual immunotherapy, not approved by the FDA for the treatment of food allergy.

Adamis Pre-Filled Syringe: Is Third Time a Charm?

An alternative to the epinephrine auto-injector has been accepted by the FDA for consideration.

Report: Panel Urges Revamp of Allergen Label Warnings

The National Academies of Sciences, Engineering and Medicine recommends changes to our ambiguous system of voluntary labeling.

FDA Director Responds to Auto-Injector Pricing Concerns

The FDA's official response concerning the pricing of EpiPen being investigated by congress.

Epinephrine Auto-injectors: Where is the Long Promised Generic?

We were supposed to have a generic alternative last year. What's holding it up and when can we expect it?

Common Additive May Be a Cause of Food Allergy

Could tert-butylhydroquinone (tBHQ) be responsible for the meteoric rise in food allergies? A researcher from the University of Michigan thinks so.