Regulatory

The FDA and AstraZeneca are both touting the agency’s approval of FluMist intranasal influenza vaccine for caregiver administration to children aged 2-17 and for self-administration by adults up to age 49. The agency agreed to… Read more . . .

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… Read more . . .

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… Read more . . .

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.… Read more . . .

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… Read more . . .

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.… Read more . . .