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Aquestive menyelesaikan pertemuan Type A FDA untuk pengajuan ulang NDA Anaphylm
Perusahaan menyelesaikan pertemuan Type A secara langsung dengan FDA dan menerima komentar awal mengenai pengajuan ulang NDA untuk Anaphylm (dibutepinephrine) sublingual film. Pertemuan ini memberikan umpan balik regulasi sebelum pengajuan ulang NDA yang direncanakan untuk pengobatan reaksi alergi Tipe 1 termasuk anafilaksis.
Fakta utama
- Diajukan
- 30 Mar 2026, 11.44
- Peristiwa
- Lainnya
- Arah
- Netral
- Perusahaan
AQSTAquestive- Aset
- epinephrine
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
Kutipan sumber
aqst-20260330 0001398733 false 0001398733 2026-03-30 2026-03-30 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of Report (Date of earliest event reported): March 30, 2026 Aquestive Therapeutics, Inc. (Exact name of Registrant as specified in its charter) Delaware 001-38599 82-3827296 (State or other jurisdiction of incorporation) (Commission File Number) (I.R.S. Employer Identification No.) 30 Technology Drive Warren , NJ 07059 ( 908 ) 941-1900 (Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant’s Principal Executive Offices) Not Applicable (Former name or former address, if changed since last report) _______________________
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AQSTAquestivePenentu
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AQSTAquestiveAquestive: dua paten baru memperluas perlindungan Anaphylm hingga 2037