Tag: Food and Drug Administration (FDA)
DBV Technologies Announces FDA Acceptance of BLA filing for Viaskin Peanut...
If approved, Viaskin Peanut would be the first and only epicutaneous immunotherapy indicated for this potentially life-threatening condition in children.
Study: Exercise and Sleep Deprivation Lower Tolerance to Peanuts in Those...
The effect is important to consider by government agencies wishing to adopt standards for allergen thresholds for food labeling.
FAQ for Palforzia, About to Become the First FDA Approved Therapy...
What it is, what it treats, who it is for, how it is used, et al.
FDA to Hold Open Advisory Meeting on AR101 Peanut Allergy OIT...
CBER will provide a live webcast of the committee meeting free of charge.
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.
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 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 and FTC Reach Settlement Over Deceptive Claims That Formula Reduces...
Agreement resolves lawsuit filed in 2014 over deceptive advertising.
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 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.
