Anaphylaxis is a serious, potentially fatal allergic reaction that can progress rapidly and involve airway compromise, hypotension, and shock. It usually develops within minutes to hours after exposure to triggers such as foods, medications, or insect stings.
Aquestive Therapeutics received a Complete Response Letter from the FDA for Anaphylm (dibutepinephrine) sublingual film, citing deficiencies in human factors validation and packaging. The company plans to resubmit as early as Q3 2026.
CSL Seqirus announced that neffy adrenaline nasal spray has been approved in Australia for emergency treatment of anaphylaxis in adults and children 15kg+ and aged four years and over, marking the first new adrenaline administration method approved in over 30 years.
The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen, for cancer patients at risk of infection due to chemotherapy and other indications. The approval marks Accord BioPharma's sixth biosimilar product.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
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COMPLETED | |
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RECRUITING |
