Regulatory
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According to MAP Pharmaceuticals, it has completed a year-long open label safety trial of its Levadex inhaled dihydroergotamine, the final step in its development program for the product. More than 250 patients completed the 12-month… Read more . . .
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The US Court of Appeals for the DC Circuit has upheld a lower court finding that the FDA lacks the authority to regulate e-cigarettes. The agency had asserted that it had jurisdication and issued warning… Read more . . .
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According to the European Medicines Agency, Schering-Plough Europe (Merck) has withdrawn its marketing authorization application for its Zenhale mometesone furoate/formoterol fumarate MDI. The company said that it was unable to provide data requested by the… Read more . . .
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According to ISTA Pharmaceuticals, the company will file an Investigational New Drug (IND) application for its bepotastine nasal spray for allergic rhinitis by the end of this year. ISTA, which already markets a bepotastine opthalmic… Read more . . .
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The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on AstraZeneca’s MAA for its Fluenz intranasal influenza vaccine for use in children. Fluenz is the same live attenuated influenza virus… Read more . . .
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Alexza Pharmaceuticals announced that it has received a complete response letter from the US FDA in regards to its application for Staccato loxapine inhalation aerosol for the treatment of agitation in schizophrenic and bi-polar patients.… Read more . . .
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The FDA has approved Pharmaxis’s Aridol mannitol inhalation powder bronchial challenge test kit. According to Pharmaxis, the Aridol test takes less than half the time of a methacholine challenge test. Aridol has already been approved… Read more . . .
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US eye care company ISTA Pharmaceuticals announced plans to file an investigational new drug (IND) application with the FDA for its bepotastine besilate nasal spray for the treatment of seasonal allergic rhinitis by the end… Read more . . .
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The European Commission’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Novartis’s TOBI Podhaler tobramycin inhalation powder for the treatment of P. aeruginosa infections in cystic fibrosis patients. Novartis submitted the… Read more . . .
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Japan has approved Daiichi Sankyo’s Inavir laninamivir dry powder inhaler for the treatment of influenza. Treatment with Inavir requires only a single inhaled 40 mg dose. Read the Daiichi Sankyo Read more . . .
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October 14-October 15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, Rockville, MD, USA
October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden
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