Tag: Food and Drug Administration (FDA)

Ben and EpiPens

The Future of EpiPen in Light of the Mylan-Pfizer Deal

An extension to the merger is being contemplated that would consolidate all aspects of the EpiPen business under one company.
Viaskin Patch

DBV Technologies Submits Biologics License Application to FDA for Viaskin Peanut...

This submission addresses the additional data needed on manufacturing procedures and quality controls which were communicated by the FDA in December.
Teva Digihaler

Teva Announces FDA Approval of First and Only Digital Inhaler with...

Bluetooth® Wireless Technology, Flow Sensors and Companion Mobile Application Track Inhaler Use in People with Asthma & COPD.
Gerber Good Start Gentle Formula

Gerber and FTC Reach Settlement Over Deceptive Claims That Formula Reduces...

Agreement resolves lawsuit filed in 2014 over deceptive advertising.
Aimmune Reponse to ICER Report

Aimmune Statement on Institute for Clinical and Economic Review (ICER) Final...

Exclusion of long-term desensitization and patient quality-of-life data by ICER fails to recognize the full value AR101 immunotherapy can deliver to the peanut allergy community.
EpiPen and Generic

Epipen Supply Status Update and Extension of Expiration Dates

Tighter supplies and greater variability in pharmacy-level access will potentially continue through the summer months as seasonal demand increases.
AR101

Aimmune Announces US FDA Advisory Committee Meeting Date for AR101 for...

The FDA will review Aimmune's Biologics Licence Application for AR101 on September 13, 2019.
EpiPen Shortage

EpiPen Shortage Will Continue for Months Longer

A source at Pfizer claims the shortage will continue for an extended time.
Stephanie Page

Watch: As the EpiPen Shortage Drags On, Chicago Mom Spells Out...

"This Is Literally The Difference Between Life And Death For My Kid."
AR101

US FDA Accepts BLA Filing of Aimmune Therapeutics’ AR101 for Peanut...

If Approved, AR101 Will Be the First Medicine for This Life-Threatening Condition.

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