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Prescription Drug User Fee Act (PDUFA)
Tag: Prescription Drug User Fee Act (PDUFA)
Aquestive Works with FDA to Resolve Hurdles for its New Sublingual...
Dave Bloom
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2026/01/09
0
FDA Won’t Require Advisory Committee Meeting for Aquestive’s Sublingual Epinephrine
News Wire ~ 3rd Party Press Release
-
2025/09/04
0
FDA Sets January 31, 2026 Target Date for Anaphylm™ Sublingual Epinephrine
Dave Bloom
-
2025/06/17
0
OptumRx, Cigna Healthcare and Navitus Health Systems add neffy® Coverage to...
News Wire ~ 3rd Party Press Release
-
2025/02/23
0
FDA Accepts neffy® Filing for Child Dose, Sets March 6 for...
Dave Bloom
-
2024/11/22
0
ARS Completes Repeat Dosing Study of Nasal Epinephrine Required by FDA...
Dave Bloom
-
2024/02/20
0
100% of Pediatric Patients with OFC Induced Anaphylaxis Responded to Single...
Dave Bloom
-
2024/02/05
0
FDA Delays Approval of neffy™ Intranasal Epinephrine Until September
Dave Bloom
-
2023/06/20
0
FDA Schedules Review of neffy®, an Intranasal Alternative to Epinephrine Auto-Injectors
Dave Bloom
-
2023/03/28
0
FDA Accepts New Drug Application for Nasal Epinephrine Spray Treatment for...
Dave Bloom
-
2022/10/21
0