Regulatory
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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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According to Cessatech, the EMA’s Committee for Medicinal Products for Human Use has adopted a negative opinion regarding Proveca’s pediatric-use marketing authorization (PUMA) of KemSu (CT001) sufentanil / ketamine nasal spray for the treatment of… Read more . . .
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Both Chiesi and the UK’s Medicines and Healthcare products Regulatory Agency have announced the MHRA’s approval of a reformulated Clenil Modulite beclometasone MDI for the treatment of asthma, marking the first approval of an MDI using Orbia‘s HFA 152a as… Read more . . .
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According to Glenmark, the FDA has approved the company’s sNDA to extend the use of Ryaltris olopatadine / mometasone nasal spray for the treatment of seasonal allergic rhinitis to patients aged 6 -12. Ryaltris was… Read more . . .
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The FDA announced that it has approved an Rx to OTC switch for Amphastar Pharmaceutical’s Rextovy 4 mg naloxone nasal spray. Amphastar’s naloxone nasal spray was initially approved for the treatment of opioid overdose by… Read more . . .
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According ALK, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved use of a 1 mg dose of EURneffy adrenaline nasal spray for the treatment of anaphylaxis in children aged 4 and older who… Read more . . .
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MannKind Corporation announced that the FDA has approved the company’s sBLA for use of Afrezza inhaled dry powder insulin for the treatment of Type 1 and Type 2 diabetes in children aged 6 and older. Afrezza was… Read more . . .
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According to Lupin, the FDA has tentatively approved the company’s ANDA for revefenacin inhalation solution, a generic of Mylan’s Yupelri inhalation solution. Yupelri was approved by the FDA for the treatment of COPD in 2018.… Read more . . .
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According to Chance Pharmaceuticals, China’s National Medical Products Administration has accepted the company’s NDA for CXG87 budesonide / formoterol DPI for the treatment of asthma. The announcement emphasizes that the formulation is Chance’s own “improved… Read more . . .
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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
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