Regulatory
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The European Commission has approved Chiesi’s Trimbow Nexthaler extrafine beclometasone dipropionate / formoterol fumarate / glycopyrronium DPI for the treatment of moderate to severe COPD in patients not adequately treated with an ICS/LABA or LABA/LAMA… Read more . . .
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Hikma Pharmaceuticals said that the FDA has approved an amendment to the company’s ANDA for its generic version of Advair Diskus fluticasone propionate / salmeterol DPI, and the company has subsequently restarted the launch of… Read more . . .
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United Therapeutics said that it has submitted an NDA for its Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and has applied a priority review voucher that it acquired for $105 million… Read more . . .
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According to Teva Pharmaceuticals Europe, the company has received marketing authorization in the EU for duplicate DPIs Seffalair Spiromax salmeterol xinafoate/ fluticasone propionate and BroPair Spiromax salmeterol xinafoate/ fluticasone propionate for the treatment for asthma… Read more . . .
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Respirent has submitted an ANDA to the FDA for its fluticasone propionate / salmeterol xinafoate DPI in 100/50 μg, 250/50 μg, and 500/50 μg dose levels for the treatment of asthma and COPD, according to… Read more . . .
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According to United Therapeutics, the FDA has approved Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD). Tyvaso has been approved for the treatment of pulmonary arterial hypertension… Read more . . .
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The UK National Institute for Health Research has designated the PROTECT-V trial of Union Therapeutics’ UNI91103 niclosamide nasal spray for the treatment of COVID-19 in kidney patients as an Urgent Public Health (UPH) priority, the… Read more . . .
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The Japanese Ministry of Health, Labour and Welfare has approved Insmed’s Arikayce amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in patients who have… Read more . . .
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Meissa Vaccines announced that the FDA has cleared the company’s IND for a Phase 1 clinical study of its MV-014-212 intranasal live attenuated vaccine candidate against SARS-CoV-2. The company announced that it had held a pre-IND… Read more . . .
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Canadian biotech SaNOtize said that a Phase 2 trial of its nitric oxide nasal spray (NONS) in COVID-19 patients demonstrated that the nasal spray reduced viral load by about 95% within 24 hours post dose… 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 10: SMI.London 2026, London, UK
July 13-July 16: 2026 ISAM Congress, Taipei, Taiwan