Regulatory
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AstraZeneca announced that the European Commission has approved the company’s Trixeo (Breztri) Aerosphere budesonide / glycopyrrolate / formoterol MDI for the treatment of asthma in patients aged 12 and older whose asthma is not adequately… Read more . . .
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Insmed announced that the FDA has accepted the company’s sNDA to expand the use of Arikayce amikacin liposome inhalation suspension for the treatment of Mycobacterium avium complex (MAC) lung disease. Arikayce is delivered by PARI‘s Lamira nebulizer. According to… Read more . . .
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California-based SMSbiotech announced that the FDA has cleared its IND for a Phase 1b trial of its inhaled small mobile stem (SMS) cell therapy in patients with COPD and that the company intends to initiate… Read more . . .
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According to Aurobindo Pharma, the FDA has issued a final approval of the company’s ANDA for 40 mcg and 80 mcg dose versions of a generic equivalent of Teva’s QVAR beclomethasone HFA MDI for the… Read more . . .
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According to Nasus Pharma, the FDA has cleared an IND for a study of Nasus’s NS002 intranasal dry powder epinephrine for the treatment of anaphylaxis. Nasus says that it also plans to initiate a pivotal… Read more . . .
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According to Hikma Pharmaceuticals, regulators in the US, Europe, and the UK have accepted submissions for the company’s epinephrine nasal spray for the treatment of anaphylaxis, and the company has also filed a submission in… Read more . . .
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According to Liquidia, the FDA has granted Fast Track designation to the company’s Yutrepia inhaled dry powder treprostinil for the treatment of Raynaud’s phenomenon associated with systemic sclerosis (SSc-RP.). Yutrepia is currently approved in the… Read more . . .
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Chiesi has announced the acceptance of regulatory submissions for two LGWP versions of its metered dose inhalers that have been reformulated with Orbia‘s HFA 152a propellant. In the UK, the MHRA recently approved Chiesi’s HFA 152a Clenil Modulite beclometasone MDI for… Read more . . .
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According to Milestone Pharmaceuticals and Everest Medicines, the Chinese National Medical Products Administration has approved Everest’s NDA for etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia. Etripamil. Everest acquired development, manufacturing, and commercialization rights… Read more . . .
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According to United Therapeutics, the FDA has accepted the company’s sNDA for Tyvaso treprostinil inhalation solution for the treatment of idiopathic pulmonary fibrosis. The FDA granted orphan drug designation to treprostinil for the treatment of… Read more . . .
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