Tag: Food and Drug Administration (FDA)
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.
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 Will Continue for Months Longer
A source at Pfizer claims the shortage will continue for an extended time.
Watch: As the EpiPen Shortage Drags On, Chicago Mom Spells Out...
"This Is Literally The Difference Between Life And Death For My Kid."
US FDA Accepts BLA Filing of Aimmune Therapeutics’ AR101 for Peanut...
If Approved, AR101 Will Be the First Medicine for This Life-Threatening Condition.
FDA Approves Dupixent® (dupilumab) for Moderate-to-severe Atopic Dermatitis in Adolescents
Therapy targets the IL-4/IL-13 pathway, a key driver of the allergic or type 2 inflammation that underlies atopic dermatitis.
EpiPen Manufacturer Under Civil Investigation by US Attorney
The company disclosed it was responding to an investigation of quality issues at the facility.
Sesame Now the Ninth Most Common Food Allergy in the US
Sesame allergy reactions often severe and increasingly prevalent, says research from the 2019 AAAAI Annual Meeting.
FDA Fast Tracks ARS-1 Intranasal Epinephrine Spray
Company provides a novel means of administering emergency epinephrine.
Government Shutdown Delays Review of AR101 Peanut Oral Immunotherapy Candidate
The FDA has shelved consideration of the drug until funding is restored.
