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FDA Complete Response Letter (CRL)
Tag: FDA Complete Response Letter (CRL)
Aquestive Resubmits Needle-Free Sublingual Epinephrine to FDA for Approval
Dave Bloom
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2026/09/17
0
Coming Soon: The Next Generation of Needle-Free Epinephrine Options
Dave Bloom
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2026/09/14
0
Sublingual Epinephrine Advances as FDA Clarifies Requirements for Approval
Dave Bloom
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2026/03/31
0
FDA Delays Approval of Aquestive’s Anaphylm™ Sublingual Epinephrine Film
Dave Bloom
-
2026/02/02
0
ARS Pharma Provides Additional Data Requested by FDA for Approval of...
Dave Bloom
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2024/04/03
0
ARS Completes Repeat Dosing Study of Nasal Epinephrine Required by FDA...
Dave Bloom
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2024/02/20
0
ARS Responds to FDA’s Request for Additional Study Before Approving neffy...
Dave Bloom
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2023/09/20
0
FDA Denies Approval of Viaskin Peanut “Patch” Therapy
Dave Bloom
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2020/08/04
0
Adamis Pre-Filled Syringe: Is Third Time a Charm?
Dave Bloom
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2017/01/20
0
Epinephrine Auto-injectors: Where is the Long Promised Generic?
Dave Bloom
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2016/07/12
0
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