Regulatory
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The FDA has approved Evoke Pharma’s Gimoti metoclopramide nasal spray for the treatment of diabetic gastroparesis, the company said. Evoke originally submitted an NDA for Gimoti in in June 2018 and acknowledged receipt of a complete response… Read more . . .
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DPI developer TFF Pharmaceuticals said that the FDA has granted orphan drug designation to its dry powder tacrolimus for the prevention of lung transplant rejection. The company also said that it plans to initiate a… Read more . . .
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United Therapeutics has filed a patent infringement suit against Liquidia Technologies in the US District Court for the District of Delaware alleging infringement of US patents 9,604,901 and 9,593,066, which protect Tyvaso treprostinil inhalation solution. Both patents… Read more . . .
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The FDA has issued new and revised product-specific guidances (PSGs) for a number of OINDPs as of June 3, 2020. The agency also updated its list of planned PSGs for complex generics, adding a number… Read more . . .
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DPI developer Iconovo announced that the company’s ICOcap capsule-based dry powder inhaler ICOcap is now CE marked for use in clinical trials. The ICOcap inhaler is available from the Stevanato Group, which signed a manufacturing,… Read more . . .
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Microbion Corporation said that its pravibismane inhalation suspension for the treatment of lung infections in patients with cystic fibrosis has been granted orphan drug designation by the FDA. Pravibismane inhalation suspension has already been granted… Read more . . .
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Propeller Health announced that the FDA has granted 510(k) clearance for the company’s inhaler monitoring sensor for AstraZeneca’s Symbicort MDI. The Propeller sensor snaps on to the inhaler and connects via Bluetooth to a mobile… Read more . . .
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Cipla said that it has received final approval for an ANDA for its generic version of Bausch’s Migranal dihydroergotamine (DHE) mesylate nasal spray for the treatment of migraine. According to Cipla, this is the company’s… Read more . . .
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The Chinese National Medical Products Administration (NMPA) has approved AstraZeneca’s Bevespi Aerosphere glycopyrronium/formoterol fumarate MDI for the treatment of COPD, the company said. AstraZeneca’s Breztri Aerosphere budesonide/glycopyrronium/formoterol fumarate MDI was approved for the treatment of COPD by… Read more . . .
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Teva Canada said that it has imported a 4-week supply of Salamol salbutamol (albuterol) sulfate MDIs through Teva UK under an interim order by the Minister of Health in response to shortages of the inhalers in Canada caused… 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
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