Regulatory
-
According to ATAI Life Sciences, the FDA has cleared an IND submitted by Neuronasal Inc. for its N-acetylcysteine (NAC). In January 2020, ATAI announced that it had partnered with Neuronasal on development of intranasal NAC… Read more . . .
-
According to AstraZeneca, the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the company’s Trixeo Aerosphere formoterol fumarate/ glycopyrronium bromide / budesonide MDI for the treatment of patients with moderate to… Read more . . .
-
Liquidia Technologies said that the US Patent Trial and Appeal Board (PTAB) has issued decisions on two patents related to Tyvaso treprostinil inhalation solution, which is marketed by United Therapeutics for the treatment of pulmonary arterial hypertension… Read more . . .
-
The FDA has granted orphan drug and rare pediatric disease designations to Spirovant Sciences’s SPIRO-2101, an inhaled adeno-associated virus (AAV) gene therapy for the treatment of cystic fibrosis, the company said. SPIRO-2101 works by replacing defective… Read more . . .
-
Hikma Pharmaceuticals and Vectura announced that the FDA has issued a minor complete response letter regarding Hikma’s ANDA for VR315 fluticasone propionate/salmeterol DPI, a generic version of GSK’s Advair Diskus. The companies say that they… Read more . . .
-
GlaxoSmithKline and Innoviva have announced that the Trelegy Ellipta fluticasone furoate / umeclidinium / vilanterol DPI has been approved by the FDA for the treatment of asthma in adult patients. The approved doses for the… Read more . . .
-
Marinomed Biotech said that it has submitted an MAA via the decentralized marketing authorization procedure for a xylometazoline decongestant nasal spray formulated with the company’s Carragelose red algae extract. The company currently markets a range… Read more . . .
-
According to Aridis Pharmaceuticals, the FDA has agreed to allow a Phase 2a trial of the company’s AR-501 nebulized formulation of gallium citrate for the treatment of lung infections in cystic fibrosis patients to skip… Read more . . .
-
Esketamine (Spravato) and sumatriptan (Tosymra) nasal sprays are among the latest set of product specific draft guidances published by the FDA. Earlier this year, the agency published a product specific guidance for sumatriptan nasal powder.… Read more . . .
-
The FDA has approved Lupin’s generic version of Teva’s ProAir HFA albuterol MDI for the treatment of asthma, the company said. Lupin said that it will manufacture the inhaler at its facility in Indore, India.… Read more . . .
Upcoming Events
Sponsored by Intertek
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
September 15-September 18: DDL New Researcher Network Summer Event, London, UK
September 16-September 17: IPAC-RS 2026 Nasal Innovation Forum, Jersey City, NJ, USA
September 24-September 25: Inhaled & Nasal Biologics | DNA Forum, Cambridge, UK
October 14-October 15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, Rockville, MD, USA
October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden