Regulatory
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Hikma Pharmaceuticals announced that the FDA has approved 100 mcg/50 mcg and 250 mcg/50 mcg doses of the company’s fluticasone propionate / salmeterol DPI (VR315), a generic version of Advair Diskus and that the company… Read more . . .
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The EU has approved AstraZeneca’s Trixeo Aerosphere (PT010) formoterol fumarate / glycopyrronium bromide / budesonide MDI for the treatment of patients with moderate to severe COPD that is not treated adequately an ICS/LABA or LABA/LAMA combination, the… Read more . . .
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Codagenix and vaccine manufacturer Serum Institute of India (SIIPL) have initiated a Phase 1 trial of COVI-VAC single-dose intranasal, live attenuated vaccine against SARS-CoV-2 after receiving approval from the MHRA, the companies said. Like Codagenix’s… Read more . . .
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The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion regarding an expanded indication for Janssen’s Spravato esketamine nasal spray on December 10, 2020. The proposed revision would add the use of Spravato… Read more . . .
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According to United Therapeutics, the FDA has granted orphan drug designation to treprostinil for the treatment of patients with idiopathic pulmonary fibrosis (IPF), with the designation’s benefits applying to both Tyvaso inhalation solution and Treprostinil… Read more . . .
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According to Florida-based startup AireHealth, the company has received 510(k) clearance from the FDA for its VitalMed connected portable vibrating mesh nebulizer. Earlier this year, AireHealth acquired BreathResearch and its VitalBreath virtual respiratory health monitoring… Read more . . .
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According to ARS Pharmaceuticals, the EMA has accepted the company’s marketing authorization application for its Neffy (ARS-1) epinephrine nasal spray for the emergency treatment of anaphylaxis. ARS recently announced that Recordati had acquired marketing rights… Read more . . .
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Altimmune announced that it has submitted an investigational new drug application to the FDA for a Phase 1 clinical study of its AdCOVID intranasal COVID-19 vaccine candidate, which it is developing in partnership with the University… Read more . . .
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Liquidia Technologies said that it has received a complete response letter in response to its NDA for LIQ861 treprostinil inhalation powder for the treatment of pulmonary arterial hypertension. The FDA accepted the 505(b)(2) NDA for… Read more . . .
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The batch of new product specific guidances published by the FDA in November 2020 include guidances for generic OINDPs referencing Valtoco diazepam nasal spray, Primatene Mist epinephrine MDI, and Spiriva Respimat tiotropium bromide SMI. The… Read more . . .
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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
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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