Tag: Food and Drug Administration (FDA)

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.
dupilumab

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 Shortage

EpiPen Manufacturer Under Civil Investigation by US Attorney

The company disclosed it was responding to an investigation of quality issues at the facility.
Sesame Seeds

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.
Nose

FDA Fast Tracks ARS-1 Intranasal Epinephrine Spray

Company provides a novel means of administering emergency epinephrine.
AR101 Delayed by Gov't Shutdown

Government Shutdown Delays Review of AR101 Peanut Oral Immunotherapy Candidate

The FDA has shelved consideration of the drug until funding is restored.

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