Regulatory
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The FDA has notified Insmed Incorporated that it will continue a clinical hold on Phase 3 trials of the company’s Arikace liposomal amikacin inhalation solution for the treatment of P. aeruginosa infections in cystic fibrosis… Read more . . .
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The US FDA has approved Boehringer Ingelheim’s Combivent Respimat tiotropium/albuterol inhalation spray for the treatment of COPD. The Combivent Respimat soft mist inhaler will replace the Combivent CFC-propelled MDI, which is to be phased out… Read more . . .
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According to the British Pharmacopoeia website: “The British Pharmacopoeia Commission has recently endorsed the formation of a new Working Party for Inhaled Products (IP). The remit of the Working Party will be to review the… Read more . . .
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Novartis has filed a marketing authorization application (MAA) with the European Medicines Agency (EMA) for its NVA237 glycopyrronium bromide dry powder inhaler, which will be called the Seebri Breezhaler. The MAA once-daily long-acting antimuscarinic (LAMA)… Read more . . .
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After the FDA’s acceptance of Alexza Pharmaceuticals’s resubmitted NDA for Adasuve, the company has announced that the Prescription Drug User Fee Act (PDUFA) goal date will be February 4, 2012. Alexza had received a complete… Read more . . .
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The FDA has approved a pre-market approval (PMA) application from Intersect ENT for its Propel mometasone furoate drug delivery implant for the treatment of chronic sinusitis. The dissolvable device is inserted in the sinus cavity… Read more . . .
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After a meeting with the FDA, MannKind Corporation has announced that the company and the agency have confirmed protocols for new efficacy and safety studies of Afrezza inhaled insulin. The original studies of Afrezza were… Read more . . .
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The US FDA has accepted the new drug application (NDA) filed by Teva on May 24, 2011 for its beclomethasone dipropionate (BDP) hydrofluoroalkane nasal spray for the treatment of seasonal allergic rhinitis (SAR) and perennial… Read more . . .
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The UK Medicines and Healthcare products Regulatory Agency (MHRA) is warning consumers against using a “fake tan nasal spray” marketed as Ubertan. According to the agency, the product comes in two versions, one of which… Read more . . .
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The US FDA has notified Insmed that it has placed a clinical hold on Insmed’s trials of Arikace liposomal amikacin for inhalation. The ongoing Phase 3 program for the use of Arikace in cystic fibrosis… 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