Regulatory
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According to Milestone Pharmaceuticals, the FDA has refused to file the company’s NDA for etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) and has “requested clarification about the time of data recorded for… Read more . . .
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According to Liquidia Corporation, the company will immediately take steps toward getting final FDA approval of Yutrepia treprostinil DPI now that the US Court of Appeals has upheld a decision by the Patent Trial and Appeal… Read more . . .
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The FDA has extended the review period for Optinose’s sNDA seeking approval of Xhance fluticasone propionate nasal spray for the treatment of chronic sinusitis in patients without nasal polyps, Optinose said. Xhance was originally approved… Read more . . .
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An FDA warning letter to Cipla dated November 17, 2023 cites numerous problems found in a February 2023 inspection of Cipla’s metered dose inhaler manufacturing facility in Pithampur, Madhya Pradesh, India. Among the issues cited… Read more . . .
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According to Ethris, a clinical trial authorization (CTA) that the company submitted to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in June 2023 has been approved, and Ethris expects to initiate a Phase… Read more . . .
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Orexo said that the FDA has accepted the company’s NDA for OX124 intranasal dry powder high dose naloxone for the reversal of opioid overdose and has set a PDUFA date of July 15, 2024. The… Read more . . .
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Lupin announced that the Drug Controller General of India approved the company’s Vilfuro-G vilanterol / fluticasone furoate / glycopyrronium bromide dry powder inhaler for the treatment of COPD, and the company has launched the DPI… Read more . . .
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The United States Federal Trade Commission (FTC) announced that it has challenged the Orange Book listings of more than 100 patents related to combination products, with most of those patents related to inhaler device components… Read more . . .
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According to Acorda Therapeutics, Biopas Laboratories has submitted marketing applications for Inbrija levodopa inhalation powder for the treatment of OFF episodes in Parkinson’s disease in Argentina, Colombia, Costa Rica, Ecuador, Panama, and Peru. In May 2022,… Read more . . .
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According to Syqe Medical, Australia’s Therapeutic Goods Administration (TGA) has approved the company’s SyqeAir cannabis inhaler, which includes 60 metered doses of milled cannabis flowers. The cartridge-based inhaler will now appear in the Australian Register… 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 9-June 10: Nasal Drug Delivery Symposium: Current Status and Future Opportunities, Stockholm, Sweden
June 10: SMI.London 2026, London, UK