Regulatory
-
Health Canada has announced that Apotex is recalling 2 lots of its mometasone nasal spray, a generic of Nasonex, due to possible contamination with Burkholderia cepacia complex. Lot TX5343 has an expiration date of September 2025, and… Read more . . .
-
Krystal Biotech announced that inhaled KB707 gene therapy for the treatment of metastasized tumors in the lung that are not successfully treated with standard therapy has been granted Fast Track designation by the FDA. The… Read more . . .
-
Lupin announced that it has launched its generic cyanocobalamin nasal spray for the prevention and treatment of vitamin B12 deficiency in the US. The FDA approved the company’s ANDA for the 500 mcg/spray intranasal cyanocobalamin… Read more . . .
-
Microbion Corporation announced that the FDA has granted orphan drug designation for pravibismane for the treatment of non-tuberculous mycobacterial (NTM) infections. Pravibismane, which Microbion is developing as a topical treatment as well as an inhalation… Read more . . .
-
Defender Pharmaceuticals announced that the FDA has issued a complete response letter in response to the NDA for DPI-386 scopolamine nasal gel that the company submitted in July 2023. The FDA accepted the NDA for… Read more . . .
-
According to Liquidia Corporation, the FDA has informed the company that the agency will not meet the PDUFA goal date of January 24, 2004 for completion of the review of Liquidia’s sNDA to add an… Read more . . .
-
According to Satsuma Pharmaceuticals parent company Shin Nippon Biomedical Laboratories, the FDA has issued a complete response letter to Satsuma’s NDA for STS101 dihydroergotamine nasal powder for the treatment of migraine. SNBL said that the… Read more . . .
-
PureIMS announced that a Phase 1 PK study that compared the company’s Levodopa Cyclops to Inbrija levodopa DPI, demonstrated “high comparability with a marketed inhaled levodopa product,” with faster initial absorption and no safety or… Read more . . .
-
Liquidia Corporation announced that it has initiated the ASCENT open-label safety and tolerability study of Yutrepia (LIQ861) treprostinil DPI in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The 52-week study is expected… Read more . . .
-
Members of the United States Senate Committee on Health, Education, Labor, and Pensions (HELP) have sent letters to the CEOs of AstraZeneca, Boehringer Ingelheim, GSK, and Teva asserting that “There is no reason for inhalers… Read more . . .
Upcoming Events
Sponsored by Intertek
Want information about upcoming OINDP-related events delivered directly to your inbox? click here
October 21-October 22: MVIC Symposium, Lund, Sweden
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland