Tag: Food and Drug Administration (FDA)

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.
Nasal Epinephrine

Update on Progress of Emergency Epinephrine Nasal Spray

The nasal spray would be an alternate means of delivering emergency epinephrine to the traditional auto-injector.
Symjepi

Symjepi, the Auto-Injector Alternative, to Launch Q1 2019

Prefilled syringe will join auto-injectors for emergency delivery of epinephrine.
Peanuts

Non-Profit Institute to Review Benefits of Commercial, Private Practice Immunotherapies for...

An independent review of the value, costs and effectiveness of Viaskin Peanut, AR101, and private practice peanut OIT.
AR101

New Treatment to Protect People with Peanut Allergies Ready for FDA...

"Two thirds of the people in the study were able to tolerate the equivalent of two peanuts per day after 9 to 12 months of treatment."
EpiPen and Carrier

FDA Alert: Some EpiPen Auto-Injectors May Not Readily Slide Out of...

In some cases, the patient or caregiver may not be able to quickly remove the epinephrine auto-injector from the carrier tube.

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