Tag: Food and Drug Administration (FDA)

Nasal Spray

FDA Grants Fast Track Designation for Epinephrine Nasal Spray as Investigational...

"A significant milestone for INSYS and our clinical development of this novel drug-device combination.”
Sen Blumenthal with EpiPen

Senator to Introduce the ‘Cure High Drug Prices Act’ Spurred On...

“We’re talking about a workhorse drug. It is a matter of life and death for kids when they have emergency reactions."
Half-Staff

Editorial: Epinephrine Auto-Injector Shortage? So What if a Few Kids Die!

Look around and see our healthcare institutions failing to keep us safe. Meanwhile, we are failing our kids.
EpiPens

Pfizer Issues Statement Extending the Expiration Date for Select Lots of...

To address shortages of EpiPen, Pfizer is coordinating with FDA to extend the expiration dates of specific lots of EpiPen® 0.3 mg Auto-Injectors.
Vibex Auto-Injector from Teva partner Antares

FDA Approves First Generic Version of EpiPen

The FDA today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector.
Xolair (omalizumab)

FDA Grants Xolair Breakthrough Therapy Designation for Food Allergies

Breakthrough Therapy Designation was granted on the basis of data from seven clinical studies assessing the efficacy and safety of Xolair against a range of food allergens including peanut, milk, egg and others.
NJ Restaurant

Town Proposes Food Allergy Regulations Among the Strictest in the Nation

Looking for ways to act locally for better allergen disclosures? Follow this town's example.
EpiPen Shortage

Pfizer Warns of Continued EpiPen Shortages for Canada as FDA Confirms...

We urge our US and Canada readers to plan ahead as back-to-school approaches.
Intravenous Drugs

FDA Establishes Task Force to Address Drug Shortages

Long term solutions are necessary but will do nothing to alleviate current shortages. The FDA must do more.

Pfizer’s Woes Go Beyond Affecting The Availability of Your Auto-Injectors

Vital drugs are in short supply at hospitals across the country forcing medical staff to substitute with less effective drugs.

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