Regulatory
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According to a LinkedIn post by generic device maker Merxin, the FDA has indicated that Merxin’s MRX004 soft mist inhaler is suitable for an ANDA submission for a generic version of Boehringer Ingelheim’s Spiriva Respimat… Read more . . .
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According to Relief Therapeutics, the FDA has granted orphan drug designation for RLF-100 inhaled aviptadil for the treatment of sarcoidosis; RLF-100 is currently in Phase 2 development for that indication. Relief also recently acquired German… Read more . . .
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Levo Therapeutics announced that the FDA has accepted the company’s NDA for LV-101 intranasal carbetocin for the treatment of excessive hunger associated with Prader-Willi syndrome (PWS) and has granted the NDA Priority Review designation, with… Read more . . .
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The Australian Therapeutic Goods Administration has issued 7 infringement notices to Starpharma regarding advertising of the company’s Viraleze astodrimer sodium antiviral nasal spray, with fines totaling $93,240. The news comes shortly after after the UK… Read more . . .
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According to Starpharma, LloydsPharmacy has paused sales of Starpharma’s Viraleze astodrimer sodium antiviral nasal spray after the UK Medicines and Healthcare products Regulatory Agency (MHRA) questioned “promotional claims, including references to SARS-CoV-2 and COVID-19, and the… Read more . . .
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SaNOtize Research and Development said that it has gotten approval from Health Canada to move ahead with two Phase 3 trials of its nitric oxide nasal spray for the prevention and treatment of COVID-19. The… Read more . . .
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Cipla and Glenmark Pharmaceuticals have announced that they have received final approval from the FDA for generic versions of Sunovion’s Brovana arformoterol tartrate inhalation solution for the treatment of COPD. Cipla said that its product… Read more . . .
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The FDA announced that it has approved Astepro azelastine hydrochloride nasal spray, 0.15%, for nonprescription use by adults and children aged 6 and older for the treatment of seasonal and perennial allergic rhinitis. Astepro Allergy… Read more . . .
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According to United Therapeutics and MannKind Corporation, the FDA has accepted United Therapeutics’ NDA for Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).… Read more . . .
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The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Lupin’s Luforbec beclometasone dipropionate / formoterol fumarate MDI, a generic version of Chiesi’s Fostair MDI, for the treatment of asthma and COPD, the company… 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