Regulatory
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Harm Reduction Therapeutics announced that it has made an initial filing for a rolling review of its NDA for RiVive naloxone nasal spray, an OTC product for the treatment of opioid overdose. In August 2022,… Read more . . .
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According to Bausch Health and Glenmark, Health Canada has approved Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis in people aged 6 and older. Bausch Health acquired the Canadian rights… Read more . . .
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According to CanSino Biologics, China’s National Medical Products Administration (NMPA) has approved the company’s Convidecia Air nebulized COVID-19 vaccine as a booster dose. In December 2021, CanSino Bio announced a deal with Aerogen for the… Read more . . .
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According to Bharat Biotech, Indian regulators have cleared its iNCOVACC (BBV154) intranasal vaccine against COVID-19 for use in adults aged 18 and older under a Restricted Use in Emergency Situation. Following the approval, Bharat Bio… Read more . . .
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The FDA has published notice of an online meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to take place on November 8, 2022 for the purpose of discussing Avillion and AstraZeneca’s NDA (214070) for PT027… Read more . . .
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The United States District Court for the District of Delaware has ruled that Liquidia’s Yutrepia treprostinil DPI would infringe claims contained in US patents 9,593,066 and 10,716,793, which cover United Therapeutics’ Tyvaso inhaled treprostinil; however,… Read more . . .
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According to Lupin, the MHRA has approved company’s Lutio tiotropium bromide inhalation powder, a generic version of Boehringer Ingelheim’s Spiriva Handihaler. The approval is the second for a Lupin OINDP in the UK; the MHRA… Read more . . .
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Adherium has submitted a 510(k) application for use of its next generation Hailie inhaler monitoring sensor with Teva’s ProAir albuterol MDI and its generic albuterol HFA MDI, the company said. Recently, the company filed a… Read more . . .
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According to Savara, the MHRA has granted Promising Innovative Medicine (PIM) designation to the company’s molgramostim inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). The PIM designation… Read more . . .
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A US District Court has ordered Wockhardt subsidiary Morton Grove Pharmaceuticals “to stop manufacturing and distributing drugs alleged to be adulterated.” The Morton Grove facility manufactured fluticasone propionate nasal sprays in addition to other products.… Read more . . .
Upcoming Events
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May 10-May 14: RDD 2026, Phoenix, AZ, USA
May 15-May 16: ATS Respiratory Innovation Summit 2026, Orlando, FL, USA
May 17-May 20: ATS International Conference 2026, Orlando, FL, USA
June 9-June 10: Nasal Drug Delivery Symposium: Current Status and Future Opportunities, Stockholm, Sweden
June 10: SMI.London 2026, London, UK