Regulatory
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ENA Respiratory announced that the US Patent and Trademark Office (USPTO) has issued a Notice of Allowance for a patent application titled “Novel molecules” (US 18/112091), which covers the company’s INNA-051 intranasal TLR2/6 agonist. According… Read more . . .
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MannKind Corporation announced that its MNKD-101 clofazimine inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung infections has been granted Fast Track designation by the FDA. MNKD-101 had already received orphan drug and qualified infectious… Read more . . .
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ARS Pharmaceuticals announced has submitted its Day 180 response regarding the company’s MAA for Neffy epinephrine nasal spray to the EMA’s Committee for Medicinal Products for Human Use (CHMP) and expects an opinion on the… Read more . . .
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MannKind Corporation announced that the FDA has cleared the company’s IND for the ICoN-1 Phase 3 study of MNKD-101 clofazimine inhalation suspension in patients with nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC). The… Read more . . .
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According to ENA Respiratory, the FDA has cleared the company’s IND for a Phase 1b study of a dry powder formulation of INNA-051, a TLR2/6 agonist, which the company has been developing as a pan-viral… Read more . . .
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Amneal Pharmaceuticals announced that it has launched a generic over-the-counter naloxone nasal spray for the reversal of opioid overdose after its ANDA for the product was approved by the FDA. Amneal had announced the agency’s… Read more . . .
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According to inhaler monitor company Adherium, the FDA has cleared the Hailie Smartinhaler sensor for use with the Airsupra albuterol / budesonide MDI and with the Breztri Aerosphere budesonide / glycopyrronium / formoterol fumarate MDI,… Read more . . .
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The Cystic Fibrosis Foundation announced that it making an additional investment of up to $8.5 million to support a Phase 2 trial of SpliSense’s nebulized SPL84 antisense oligonucleotide in patients with cystic fibrosis associated with the… Read more . . .
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ARS Pharmaceuticals said that it has submitted its response to the complete response letter it received from the FDA in September 2023 regarding the company’s NDA for Neffy epinephrine nasal spray for the treatment of allergic… Read more . . .
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Liquidia Corporation announced today that the expiration of United Therapeutics’ new clinical investigation exclusivity for the use of Tyvaso treprostinil to treat pulmonary hypertension associated with interstitial lung disease (PH-ILD) on March 31, 2024, along with… 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