Calls for papers
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Viatris and Kindeva Drug Delivery have announced the launch of Breyna budesonide / formoterol fumarate MDI, a generic version of AstraZeneca’s Symbicort, for the treatment of asthma in patients aged 6 and over and for the treatment… Read more . . .
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Marinomed Biotech said that its partner M8 Pharmaceuticals has received marketing authorization for Carragelose iota-carrageenan nasal spray in Mexico. M8 acquired the rights to market the nasal spray in Mexico and Brazil in 2021. According… Read more . . .
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Defender Pharmaceuticals announced that it has submitted an NDA for its DPI-386 scopolamine nasal gel for the prevention of motion sickness in adults. According to the company’s web site, Defender has worked with the US… Read more . . .
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The FDA announced that it has approved Harm Reduction Therapeutic’s NDA for RiVive naloxone nasal spray for the reversal of opioid overdose. Harm Reduction initiated a rolling NDA submission for RiVive in October 2022, and… Read more . . .
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Liquidia Corporation announced that it has submitted an sNDA for its Yutrepia treprostinil DPI, which was tentatively approved by the FDA in November 2021 for the treatment of pulmonary arterial hypertension (PAH). The supplemental application is… Read more . . .
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Krystal Biotech announced that it will develop injectable and inhaled versions of its KB707 gene therapy for the treatment of malignant solid tumors, including metastatic cancer. The company said that it intends to amend an… Read more . . .
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Amneal Pharmaceuticals announced that it has submitted ANDAs for three complex generics, including a generic version of Teva’s ProAir HFA albuterol sulfate metered dose inhaler. Currently, the only listed therapeutic equivalent for ProAir HFA is… Read more . . .
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According to Lupin, the company’s generic version of Boehringer Ingelheim’s Spiriva Handihaler tiotropium bromide DPI has been approved for the treatment of COPD by Australia’s Therapeutic Goods Administration (TGA). Lupin said that it will manufacture… Read more . . .
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The Court of Appeals for the Federal Circuit has upheld rulings by the United States District Court for the District of Delaware in a patent infringement suit filed by United Therapeutics against Liquidia Corporation alleging that Liquidia’s… Read more . . .
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Insilico Medicine, which claims to be “a generative artificial intelligence (AI)-driven clinical-stage drug discovery company,” said that it is “the first AI drug discovery company to venture into nebulized formulations” as the company plans to… 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