Regulatory

Silo Pharma announced that it has received responses from the FDA following a pre-IND meeting regarding SPC-15 soft mist intranasal ketamine for post-traumatic stress disorder (PTSD) and stress-induced anxiety disorder. Silo is planning to take advantage of the 505(b)(2) pathway for SPC-15, which it has licensed from Columbia University. In November 2023, Silo … [Read more...] about Silo Pharma says that it completed pre-IND meeting with the FDA regarding SPC-15 intranasal ketamine for PTSD and anxiety

ARS Pharmaceuticals announced that it has submitted a supplemental NDA for Neffy 1 mg epinephrine nasal spray for the treatment of anaphylaxis in children weighing 15 to 30 kg (33-66 lbs). The FDA recently approved a 2 mg dose of Neffy for the treatment of anaphylaxis in patients weighing 30 kg or more. At that time, the company said that it intended to submit the … [Read more...] about ARS Pharmaceuticals submits sNDA for Neffy 1 mg epinephrine nasal spray for anaphylaxis in small children

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

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

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

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

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