Tag: Food and Drug Administration (FDA)

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.
Eating While Pregnant

Study: No Link Found Between Mother-to-Be’s Diet and Baby’s Risk for...

No more guilt: avoidance diet was not shown to make a difference
AR101

Aimmune Submits FDA Application to Offer AR101 for the Treatment of...

“We have requested FDA Priority Review and look forward to working with the agency to bring what could be the first approved treatment in food allergy to patients as quickly as possible.”
Viaskin Peanut

DBV Withdraws FDA Application for Viaskin Peanut with Plan to Resubmit

The company believes the additional information needed to support this filing is available without further clinical studies.

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