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Regulatory

SyqeAir cannabis inhaler gets TGA approval

According to Syqe Medical, Australia's Therapeutic Goods Administration (TGA) has approved the company's SyqeAir cannabis inhaler, which includes 60 metered doses of milled cannabis flowers. The cartridge-based inhaler will now appear in the Australian Register of Therapeutic Goods (ARTG). Novachem sponsored the application and will distribute SyqeAir in Australia. … [Read more...] about SyqeAir cannabis inhaler gets TGA approval

FDA accepts AstraZeneca’s sBLA for self-administration of FluMist Quadrivalent intranasal flu vaccine

According to AstraZeneca, the FDA has accepted for review the company's supplemental biologics license application (sBLA) for self-administration of FluMist Quadrivalent nasal spray vaccine against influenza. AstraZeneca says that it expects a PDUFA date in the first quarter of 2024, which would allow for self administration of FluMist for the 2024-25 flu season if … [Read more...] about FDA accepts AstraZeneca’s sBLA for self-administration of FluMist Quadrivalent intranasal flu vaccine

Milestone submits NDA for etripamil nasal spray for the treatment of PVST

Milestone Pharmaceuticals said that it has submitted an NDA for its etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) and that the FDA has conditionally approved the proposed trade name "Cardamyst." The company said that it is continuing preparations for an anticipated commercial launch. According to Milestone, the clinical … [Read more...] about Milestone submits NDA for etripamil nasal spray for the treatment of PVST

FDA okays home dosing of Tiziana’s intranasal foralumab for MS patients in expanded access program

According to Tiziana Life Sciences, the FDA is allowing patients with multiple sclerosis who are taking part in an expanded access program through Brigham and Women's Hospital to use intranasal foralumab at home instead of at the hospital. In April 2022, the company announced that the agency had agreed to allow the access program to expand to a total of 10 patients … [Read more...] about FDA okays home dosing of Tiziana’s intranasal foralumab for MS patients in expanded access program

Aculys says it will file NDA based on interim analysis of Japanese Phase 3 trial of NRL-1 (Valtoco) diazepam nasal spray

Aculys Pharma says that it plans to move ahead with submission of a marketing application to Japanese authorities based on interim data showing that a Japanese Phase 3 clinical study of NRL-1 diazepam nasal spray in epilepsy patients aged 6 to 17 met its primary efficacy endpoint. Aculys acquired development and commercialization rights to Neurelis's NRL-1 diazepam … [Read more...] about Aculys says it will file NDA based on interim analysis of Japanese Phase 3 trial of NRL-1 (Valtoco) diazepam nasal spray

FDA places clinical hold on GH Research IND for GH001 inhaled 5-MeO-DMTFDA

GH Research announced that the FDA has placed a clinical hold on an IND that the company submitted for GH001 inhaled mebufotenin (5-MeO-DMT) for the treatment of treatment-resistant depression, citing "Insufficient information to assess risks to human subjects." The company said that it is waiting to learn more details from the FDA about the reasons for the clinical … [Read more...] about FDA places clinical hold on GH Research IND for GH001 inhaled 5-MeO-DMTFDA

FDA accepts Defender’s NDA for DPI-386 scopolamine nasal gel for priority review

According to Defender Pharmaceuticals, the FDA has accepted the company’s NDA for DPI-386 scopolamine nasal gel for the treatment of motion sickness for priority review, with a PDUFA goal date of January 26, 2024. Defender submitted the NDA in July 2023. The company said that the FDA granted priority review at the request of the US Navy. Defender President and CEO … [Read more...] about FDA accepts Defender’s NDA for DPI-386 scopolamine nasal gel for priority review

FDA sets PDUFA date for Liquidia’s sNDA to add PH-ILD indication for Yutrepia treprostinil DPI

Liquidia Corporation said that the FDA has accepted its sNDA to add pulmonary hypertension associated with interstitial lung disease (PH-ILD) as an indication for Yutrepia treprostinil inhalation powder without requiring any additional studies and has set the PDUFA goal date as January 24, 2024. The FDA tentatively approved Yutrepia for the treatment of … [Read more...] about FDA sets PDUFA date for Liquidia’s sNDA to add PH-ILD indication for Yutrepia treprostinil DPI

Krystal Biotech announces plans for Phase 1 trial of KB408 inhaled gene therapy for the treatment of AAT

Krystal Biotech said that the FDA has cleared an IND for KB408 nebulized gene therapy for the treatment of alpha-1 antitrypsin deficiency, and the company said that it plans to initiate a Phase 1 trial in early 2024. According to Krystal, the study will evaluate 3 ascending doses of KB408 in adult patients with AAT deficiency who have a PI*ZZ genotype. KB408 is … [Read more...] about Krystal Biotech announces plans for Phase 1 trial of KB408 inhaled gene therapy for the treatment of AAT

FDA issues CRL to ARS’ NDA for Neffy intranasal epinephrine for the treatment of allergic reactions

According to ARS Pharmaceuticals, the FDA has issued a complete response letter to the company's NDA for Neffy epinephrine nasal spray for the treatment of allergic reactions, including anaphylaxis, and the agency has requested the completion of a PK/PD repeated-dose study prior to approval. The CRL also asked for more information on nitrosamine impurities, which the … [Read more...] about FDA issues CRL to ARS’ NDA for Neffy intranasal epinephrine for the treatment of allergic reactions

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