Regulatory
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According to Insmed, the US FDA has lifted the clinical hold on Arikace liposomal amikacin for inhalation for the treatment of patients with non-tuberculous mycobacteria (NTM) lung disease. In October 2011, the FDA had asked… Read more . . .
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Mumbai-based pharmaceutical and biotechnology company Wockhardt says that it will launch its generic version of GSK’s Flonase fluticasone nasal spray in the US immediately after having received approval from the US FDA. The company will… Read more . . .
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GlaxoSmithKline and Theravance have announced the completion of Phase 3 studies of their Relovair fluticasone furoate/vilanterol DPI for COPD. One Phase 3 study for the treatment of asthma remains to be completed. Despite the fact… Read more . . .
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Pharmaxis has announced that it “filed a minor resubmission with the Pharmaceutical Benefits Advisory Committee (PBAC)” for its Bronchitol mannitol dry powder inhaler for the treatment of cystic fibrosis. According to the company, the committee’s… Read more . . .
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In an article in the December 15 issue of the New England Journal of Medicine, regulators from the FDA’s Center for Drug Evaluation and Research (CDER), with Badhul Chowdhury, director of Division of Pulmonary, Allergy,… Read more . . .
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After meeting to discuss concerns about the safety of Alexza Pharmaceutical’s Adasuve Staccato loxapine, the FDA’s Psychopharmacologic Drugs Advisory Committee voted 9 to 8, with 1 abstention, to recommend approval for a single dose in… Read more . . .
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The US FDA has announced a December 12 meeting of the Psychopharmacologic Drugs Advisory Committee to discuss safety concerns related to Alexza’s Adasuve loxapine inhalation powder for the treatment of agitation associated with schizophrenia or… Read more . . .
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Shortly after announcing a co-promotion deal with Eisai for its inhaled COPD drugs in Japan, Novartis has filed a new drug application in that country for one of those drugs, NVA237 inhaled glycopyrronium bromide, according… Read more . . .
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Within the last week, Discovery Laboratories has announced that its aerosolized KL4 surfactant has received orphan drug designation from the EU for the treatment of cystic fibrosis, and it has presented data on a new… Read more . . .
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US Senator Jim DeMint, a Republican from South Carolina, failed to persuade the US Senate to prohibit the use of tax dollars for enforcement of the FDA ban on the CFC-propelled OTC epinephrine inhaler Primatene… Read more . . .
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