Regulatory
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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 . . .
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The FDA has approved Alembic Pharmaceuticals’ ANDA for its formoterol fumarate inhalation solution, a generic of Mylan’s Perforomist inhalation solution for the treatment of COPD, the company said. According to the announcement, this is the… Read more . . .
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Janssen Pharmaceutical announced that it has launched Spravato esketamine nasal spray in Australia for the treatment of treatment-resistant depression following approval by the TGA. The company also said that will file a submission to the… Read more . . .
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According to Tonix Pharmaceuticals, the FDA has cleared the company’s IND for a Phase 2 study of TNX-1900 potentiated oxytocin nasal spray for the prevention of migraine headache. Tonix acquired the rights to the intranasal… Read more . . .
Upcoming Events
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December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
May 12-13: USP Joint Workshop: Quality and Product Performance Testing of Orally Inhaled and Nasal Drug Products, Rockville, MD, USA
June 30: RespireX 2027, Boston, MA, USA