News
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According to an FDA spokesperson, the FDA Nonprescription Drugs Advisory Committee (NDAC) and Pulmonary Allergy Drugs Advisory Committee (PADAC) voted not to support approval of Armstrong Pharmaceuticals’ NDA for Primatene HFA during a joint meeting… Read more . . .
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As of February 26, 2014, filling and packaging systems maker ITCM has changed its name to Molins Technologies, bringing the company’s brand into line with parent company Molins PLC. As part of the rebranding effort,… Read more . . .
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Alexza Pharmaceuticals has announced the hire of Robert A. Lippe as Executive VP, Operations and Chief Operations Officer. Lippe was most recently Head of Global Operations & Operational Excellence at Ironwood Pharmaceuticals. The company is… Read more . . .
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Fresenius Kabi USA has announced the immediate availability of 4 ml vials of 20% acetylcysteine solution for inhalation. The company has offered 10 ml vials since 2012 and 30 ml vials since 2013. Acetylcysteine solution… Read more . . .
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Shortly after announcing that the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion regarding Anoro umeclidinium/vilanterol, GSK has announced that CHMP also issued a positive opinion regarding umeclidinium monotherapy. According… Read more . . .
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St. Renatus has announced the completion of adult and pediatric Phase 3 clinical studies of its nasal mist dental anesthesia and says that it is now working on data analysis with the goal of submitting… Read more . . .
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According to Teva, the company’s DuoResp Spiromax budesonide/formoterol fumarate inhalation powder has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP). The company has applied to market the product… Read more . . .
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Invion will work with 3M Drug Delivery Systems to develop inhaled formulations of nadolol and zafirlukast to be delivered using 3M’s MDI technology. If inhaled delivery of INV102 (nadolol) and INV104 (zafirlukast) for the treatment… Read more . . .
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Tonya Winders, President and CEO of Allergy & Asthma Network Mothers of Asthmatics (AANMA) will speak in opposition to the approval of Primatene HFA at the upcoming joint meeting of the FDA’s Nonprescription Drugs Advisory… Read more . . .
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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Anoro umeclidinium/vilanterol for the treatment of COPD, GlaxoSmithKline and Theravance have announced. The dosage would be 55 mcg/22… Read more . . .
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