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Mar 20, 2026
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.
Feb 16, 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.
Jan 16, 2026
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.
