Regulatory
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Glenmark Pharmaceuticals and SaNOtize have announced the approval of FabiSpray nitric oxide nasal spray (NONS) for the treatment of COVID-19 by the Drugs Controller General of India (DCGI) and the launch of the nasal spray… Read more . . .
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The FDA has now fully approved Lupin’s ANDA for its generic version of Sunovion’s Brovana arformoterol tartrate inhalation solution for the treatment of COPD. Brovana was approved by the FDA in 2006. The agency tentatively… Read more . . .
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Celltrion Group announced that it has submitted an IND application for a Phase 3 trial of an inhaled COVID-19 antibody cocktail for the treatment of mild-to-moderate COVID-19. In July 2021, Celltrion announced that it had… Read more . . .
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Levo Therapeutics announced that the FDA has issued a complete response letter to the company’s NDA for LV-101 intranasal carbetocin for the treatment of excessive hunger and anxiety associated with Prader-Willi syndrome (PWS). The FDA… Read more . . .
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Glenmark Pharmaceuticals announced that it has received FDA approval of its NDA for Ryaltris olopatadine hydrochloride / mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis in patients aged 12 and older. The… Read more . . .
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Israeli biopharm SpliSense has announced that both the FDA and the EMA have granted orphan drug designation to the company’s SPL84-23-1 inhaled antisense oligonucleotide (ASO) for the treatment of cystic fibrosis associated with the 3849+10… Read more . . .
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According to Iliad Biotechnologies, the FDA has granted Fast Track designation to Iliad’s BPZE1 live attenuated intranasal vaccine against pertussis (whooping cough), which is in Phase 2 development as a booster vaccine to prevent both… Read more . . .
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US-based Ritedose Pharmaceuticals, a subsidiary of CDMO Ritedose Corporation, has announced the launch of generic unit dose budesonide inhalation suspension (0.5 mg/2 ml) packaged for use in hospitals. Also, at the end of December, the… Read more . . .
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According to Liquidia Corporation, United Therapeutics has agreed to a court judgment finding that Liquidia did not infringe United Therapeutic’s US Patent No. 9,604,901. In October 2021, an inter partes review by the US Patent Trial and Appeal… Read more . . .
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According to Kenox Pharmaceuticals, the company “received a positive response supporting the planned CMC, non-clinical and clinical development strategy” following a pre-IND meeting with FDA regarding the company’s KNX018 inhaled sensitizer for use with radiation… Read more . . .
Upcoming Events
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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