According to Arcturus Therapeutics, the FDA has cleared an investigational new drug application allowing the company to proceed with a Phase 2 MAD trial of its ARCT-032 inhaled mRNA therapy in people with cystic fibrosis. The nebulized therapy, which is designed to deliver CFTR mRNA, has both orphan drug and rare pediatric disease designations from the FDA and orphan … [Read more...] about FDA clears IND for Phase 2 trial of Arcturus’ ARCT-032 inhaled mRNA therapy in CF patients
Regulatory
ARS Pharma’s EURneffy adrenaline nasal spray approved in Europe
ARS Pharmaceuticals announced that the European Commission has approved the company's EURneffy adrenaline nasal spray for the treatment of anaphylaxis. The approval comes soon after the FDA's approval of the US version, Neffy epinephrine nasal spray. The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding the EURneffy MAA in … [Read more...] about ARS Pharma’s EURneffy adrenaline nasal spray approved in Europe
FDA tentatively approves Liquidia’s sNDA for Yutrepia treprostinil DPI to add PH-ILD as an indication
According to Liquidia Corporation, the FDA has granted tentative approval of the company's sNDA for Yutrepia dry powder treprostinil for inhalation powder to add pulmonary hypertension associated with interstitial lung disease (PH-ILD) as an indication. In November 2021, the FDA tentatively approved Yutrepia for the treatment of pulmonary arterial hypertension … [Read more...] about FDA tentatively approves Liquidia’s sNDA for Yutrepia treprostinil DPI to add PH-ILD as an indication
FDA approves ARS Pharmaceutical’s Neffy intranasal epinephrine for the treatment of anaphylaxis
The FDA has approved ARS Pharmaceutical's NDA for Neffy epinephrine nasal spray for the treatment of Type 1 allergic reactions, including anaphylaxis, in patients who weigh 30 kg or greater. In response, ARS Pharma announced that the product should be available in the US within 8 weeks and also said that it plans to submit an sNDA seeking approval for the use of Neffy … [Read more...] about FDA approves ARS Pharmaceutical’s Neffy intranasal epinephrine for the treatment of anaphylaxis
Tiziana’s intranasal foralumab for the treatment of non-active secondary progressive MS gets Fast Track designation
The FDA has granted Fast Track designation to Tiziana Life Sciences' intranasal foralumab, an anti-CD3 monoclonal antibody, for the treatment of non-active secondary progressive multiple sclerosis (na-SPMS), the company said. Tiziana is also developing intranasal foralumab for the treatment of Alzheimer's disease and has announced plans to develop the nasal … [Read more...] about Tiziana’s intranasal foralumab for the treatment of non-active secondary progressive MS gets Fast Track designation
Emergent BioSolutions’ Narcan naloxone nasal spray gets shelf-life extension in Canada
According to Emergent BioSolutions, the shelf life for newly manufactured Narcan naloxone nasal spray has been extended to 48 months; the previous shelf life was 36 months. Narcan has been approved for the reversal of opioid overdose in Canada since October 2016. Emergent Senior VP, Head of Products Business, Paul Williams commented, “Helping to save lives from … [Read more...] about Emergent BioSolutions’ Narcan naloxone nasal spray gets shelf-life extension in Canada
J&J submits sNDA for Spravato esketamine nasal spray as a monotherapy for treatment-resistant depression
Johnson & Johnson said that it has submitted an sNDA to the FDA for the use of Spravato esketamine CIII nasal spray as a monotherapy for the treatment of treatment-resistant depression. In 2019, the FDA approved an NDA submitted by J&J subsidiary Janssen Pharmaceuticals (now Johnson & Johnson Innovative Medicine) for the use of Spravato with an oral … [Read more...] about J&J submits sNDA for Spravato esketamine nasal spray as a monotherapy for treatment-resistant depression
FDA issues CRL to Orexo’s resubmitted NDA for OX124 naloxone nasal powder
The FDA has issued a complete response letter to Orexo's NDA for OX124 intranasal dry powder naloxone for the reversal of opioid overdose, the company said. Orexo resubmitted the NDA in September 2023 after the agency rejected its first application due to concerns about the packaging process. The NDA had been initially submitted in early 2023. The FDA accepted the … [Read more...] about FDA issues CRL to Orexo’s resubmitted NDA for OX124 naloxone nasal powder
FDA allows expansion of Phase 2a trial NeOnc’s NEO100 intranasal perillyl alcohol to include additional type of brain tumor
According to NeOnc Technologies, the FDA has approved an expansion of an ongoing Phase 2a trial of the company's NEO100 intranasal perillyl alcohol to include patients with recurrent grade 3 astrocytoma with isocitrate dehydrogenase 1 (IDH1) mutation. NeOnc announced the initiation of the trial, which initially focused on treatment of grade 4 gliomas, in May 2016. The … [Read more...] about FDA allows expansion of Phase 2a trial NeOnc’s NEO100 intranasal perillyl alcohol to include additional type of brain tumor
CHMP recommends approval of ARS’s EURneffy adrenaline (epinephrine) nasal spray for anaphylaxis
ARS Pharmaceuticals announced that the EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding the company's MAA for the European version of its Neffy epinephrine nasal spray. In April 2024, ARS announced that it had submitted a Day 180 response regarding the MAA for the nasal spray to CHMP. If approved, the European … [Read more...] about CHMP recommends approval of ARS’s EURneffy adrenaline (epinephrine) nasal spray for anaphylaxis