Anaphylaxis
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CLINICAL_TRIALS research · 2026-04-20Clinical Trial Update: Screening Protocol for Genetic Diseases of Allergic Inflammation
Completed clinical trial update describing a screening protocol for genetic diseases involved in allergic inflammation.
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EMA approval · 2026-04-07EMA Authorised: Eurneffy (epinephrine) — ALK-Abelló A/S
EMA authorised Eurneffy for the treatment of anaphylaxis; the marketing authorisation holder is ALK-Abelló A/S.
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FDA approval · 2026-03-30FDA Approved: EPINEPHRINE — Original Application (Baxter Healthcare Corporation)
FDA approved Baxter's Original Application for EPINEPHRINE, enabling the marketing of an epinephrine product. The approval covers emergency …
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CLINICAL_TRIALS trial_result · 2026-03-30Clinical Trial Update: PK/PD Study of IN-001 Sublingual Spray in Healthy Adults [Phase 1]
Phase 1 PK/PD study of IN-001 Sublingual Spray in healthy adults is currently recruiting to characterize pharmacokinetics and pharmacodynami…
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FDA approval · 2026-03-26FDA Approved: NEFFY — Supplemental Application (ARS Pharmaceuticals Operations, Inc.)
FDA approved a supplemental NDA for NEFFY (epinephrine) from ARS Pharmaceuticals Operations, Inc., expanding its use for emergency treatment…
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FDA label_change · 2026-03-20FDA Approved: EPIPEN — Supplemental Application (Viatris Specialty LLC)
FDA approves a supplemental application for EPIPEN (epinephrine) by Viatris Specialty LLC, indicating changes to the product labeling.
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CLINICAL_TRIALS research · 2026-02-10Clinical Trial Update: The Effect of Post-Scenario Debriefing and Rapid Cycle Deliberate Practice in Anaphylactic Shock Training on Nursing Students' Knowledge, Performance, Self-Confidence, and Satisfaction [NA]
A clinical trial update evaluating how post-scenario debriefing and rapid cycle deliberate practice affect nursing students' knowledge, perf…
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CLINICAL_TRIALS research · 2026-02-05Clinical Trial Update: Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing, Immunotherapy or Oral Challenges [Phase 1]
Phase 1 trial studying whether inhaled epinephrine can lessen systemic allergic reactions during allergy testing, immunotherapy, or oral cha…
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CLINICAL_TRIALS research · 2026-01-27Clinical Trial Update: Steroid Use in Treatment of Allergic Reactions to Food [Phase 4]
This entry notes an ongoing Phase 4 clinical trial evaluating steroid use for treating allergic reactions to food, with recruitment currentl…
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CLINICAL_TRIALS research · 2026-01-09Clinical Trial Update: Analysis of the Role of IgE Proteoforms in Health and Disease
KU Leuven is updating on a clinical trial studying the role of IgE proteoforms in health and disease, with recruitment ongoing across severa…
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FDA approval · 2025-12-08FDA Approved: EPINEPHRINE — Original Application (Amneal Pharmaceuticals Private Limited)
The FDA approved Amneal Pharmaceuticals' generic Epinephrine product under an Original Application (ANDA), authorizing its marketing.
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CLINICAL_TRIALS research · 2025-11-24Clinical Trial Update: Diagnosis and Allergen Identification of Perioperative Anaphylaxis
A clinical trial update indicating recruitment for a study on diagnosis and allergen identification of perioperative anaphylaxis, including …
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CLINICAL_TRIALS trial_result · 2025-11-17Clinical Trial Update: Observation Periods and Biphasic Reaction Risk Factors in Pediatric Emergency Anaphylaxis Cases
Completed pediatric trial examining observation periods and risk factors for biphasic reactions in emergency department cases of anaphylaxis…
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CLINICAL_TRIALS trial_result · 2025-11-14Clinical Trial Update: Comparative PK/PD of FMXIN002 and EpiPen, in Healthy Adults With Allergic Rhinitis [Phase 1, Phase 2]
A clinical trial update comparing the pharmacokinetics and pharmacodynamics of FMXIN002 versus EpiPen in healthy adults with allergic rhinit…
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FDA approval · 2025-10-24FDA Approved: NEFFY — Supplemental Application (ARS Pharmaceuticals Operations, Inc.)
FDA approves a supplemental application for NEFFY (epinephrine) by ARS Pharmaceuticals Operations, Inc., authorizing changes to the product'…
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FDA approval · 2025-10-14FDA Approved: EPINEPHRINE — Original Application (Amneal Pharmaceuticals LLC)
FDA approves Amneal Pharmaceuticals' original application for a generic epinephrine product.
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CLINICAL_TRIALS trial_result · 2025-09-08Clinical Trial Update: Standardised Drug Provocation Testing in Perioperative Hypersensitivity [NA]
A completed clinical trial examining standardized drug provocation testing for perioperative allergic reactions and related hypersensitivity…
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CLINICAL_TRIALS trial_result · 2025-08-19Clinical Trial Update: Predicting Peanut Anaphylaxis and Reducing Epinephrine [NA]
This clinical trial update reports completion and posted results on predicting peanut-related anaphylaxis and reducing epinephrine use. The …
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CLINICAL_TRIALS trial_result · 2025-07-25Clinical Trial Update: Effects of Inhaled Epinephrine on Systemic Allergic Reactions During Allergy Testing Immunotherapy or Oral Challenges [Phase 1]
Phase 1 trial evaluating inhaled epinephrine to attenuate systemic allergic reactions during allergy testing and oral challenges has complet…
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CLINICAL_TRIALS trial_result · 2025-07-24Clinical Trial Update: Hymenoptera Venom Immunotherapy: Evaluation of Its Long-term Efficacy at the University Hospital of Angers (EFLOTITA2)
This completed clinical trial at University Hospital Angers evaluated the long-term efficacy of Hymenoptera venom immunotherapy for preventi…
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CLINICAL_TRIALS research · 2025-07-01Clinical Trial Update: FMXIN002 in Patients at Risk of Anaphylaxis [Phase 2, Phase 3]
Nasus Pharma reports ongoing Phase 2 and Phase 3 clinical trials of FMXIN002 for individuals at risk of anaphylaxis due to food. Enrollment …
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FDA approval · 2025-06-30FDA Approved: EPINEPHRINE — Supplemental Application (BPI Labs, LLC)
FDA approved a supplemental application for epinephrine from BPI Labs, LLC, confirming regulatory action on the product.
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CLINICAL_TRIALS trial_result · 2025-06-18Clinical Trial Update: Comparative Bioavailability of Intranasal Epinephrine [Phase 1, Phase 2]
A Phase 1/2 clinical trial evaluating the comparative bioavailability of intranasal epinephrine for anaphylaxis has completed.
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CLINICAL_TRIALS trial_result · 2025-06-18Clinical Trial Update: A Study About the Use of Omalizumab in the Treatment of Food Allergy and Anaphylaxis
A completed clinical study evaluated the use of omalizumab for food allergy and related anaphylaxis.
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FDA approval · 2025-06-03FDA Approved: EPINEPHRINE — Original Application (GLENMARK PHARMACEUTICALS INC., USA)
FDA approves Glenmark's generic epinephrine injection under Original Application (ANDA 218144), enabling its marketing in the United States.…