Tag: Food and Drug Administration (FDA)
Symjepi, the Auto-Injector Alternative, to Launch Q1 2019
Prefilled syringe will join auto-injectors for emergency delivery of epinephrine.
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.
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."
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.
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."
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."
Aimmune Therapeutics Announces Initiation of Phase 2 Study of AR101 With...
Trial Will Build on the Positive, Pivotal Phase 3 PALISADE Trial of AR101.
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.
Additional Symjepi Dosage Strength Approved for Anaphylaxis Treatment
"We are working closely with Sandoz to bring this product to market."
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.”
