Tag: Food and Drug Administration (FDA)

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.
Sesame Seeds

FDA Commissioner’s Statement on the Consideration of Labeling for Sesame as...

"The FDA is advancing a new effort for the consideration of labeling for sesame to help protect people who have sesame allergies."
Viaskin Peanut

DBV Applies for FDA License to Sell Viaskin Peanut Patch Therapy

"This submission represents a significant step forward for those families living with peanut allergy."
AR101+dupilumab

Aimmune Therapeutics Announces Initiation of Phase 2 Study of AR101 With...

Trial Will Build on the Positive, Pivotal Phase 3 PALISADE Trial of AR101.
EpiPens

Editorial: Reasons to Not Accept as Gospel the Current Configurations of...

Numerous studies indicate current auto-injector configurations may be less than optimal to the task of combating anaphylaxis for a significant portion of the population.
Symjepi

Additional Symjepi Dosage Strength Approved for Anaphylaxis Treatment

"We are working closely with Sandoz to bring this product to market."
Nasal Spray

FDA Grants Fast Track Designation for Epinephrine Nasal Spray as Investigational...

"A significant milestone for INSYS and our clinical development of this novel drug-device combination.”

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