Regulatory
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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 . . .
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Milestone Pharmaceuticals announced that it has resubmitted its NDA for etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT). The FDA had issued a Refuse to File letter in December 2023 in response to… Read more . . .
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October 21-October 22: MVIC Symposium, Lund, Sweden
October 28-October 30: Deutches Aerosol Therapie Symposium (DATS), Marburg, Germany
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland