Regulatory
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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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Aurobindo Pharma announced that its newly-acquired US subsidiary Lannett has launched 100/50 mcg and 250/50 mcg strengths of a generic version of Advair Diskus fluticasone propionate / salmeterol xinafoate DPI in the US. Aurobindo notes that… Read more . . .
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Silo Pharma gets notice of allowance for Canadian patent covering SPC-15 intranasal therapy for PTSD
According to Silo Pharma, the company has received a notice of allowance from the Canadian Intellectual Property Office related to a patent application titled “Prophylactic Efficacy of Serotonin 4 Receptor Agonists Against Stress,” covering SPC-15… Read more . . .
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According to Rein Therapeutics, the FDA has granted the company’s LTI-03 inhaled dry powder synthetic peptide Fast Track designation for the treatment of idiopathic pulmonary fibrosis. The company notes that the FDA previously granted orphan… Read more . . .
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Gossamer Bio announced that it has reacquired the ex-US rights to its seralutinib dry powder inhaler for the treatment of pulmonary hypertension from Chiesi, which acquired the rights to the seralutinib DPI in 2024. According to… Read more . . .
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According to Cipla, the FDA has approved the company’s ANDA for 100/50 mcg, 250/50 mcg, and 500/50 mcg strengths of its generic version of Advair Diskus fluticasone propionate / salmeterol DPI for the treatment of… Read more . . .
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September 15-September 18: DDL New Researcher Network Summer Event, London, UK
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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