Regulatory
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According to Circassia Pharmaceuticals, the FDA has accepted its NDA for the Duaklir aclidinium/formoterol DPI for the treatment of COPD and an sNDA for the Tudorza aclidinium bromide DPI, with a PDUFA date of March… Read more . . .
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US-based Onspira Therapeutics has announced that its OSP-101, an inhaled interleukin-1 receptor antagonist (IL-1Ra) for the treatment of bronchiolitis obliterans, has been granted orphan drug designation by the FDA. Onspira is a private company created… Read more . . .
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UCB announced that the FDA has accepted its new drug application for USL261 midazolam nasal spray for the rescue treatment of seizures in epilepsy patients. The company announced in April 2018 that it had acquired… Read more . . .
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The FDA’s Antimicrobial Drugs Advisory Committee (AMDAC) voted against the efficacy and safety of Insmed’s ALIS amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC)… Read more . . .
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The FDA has accepted Glenmark Pharmaceuticals’ NDA for Ryaltris olopatadine hydrochloride/mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis, with the PDUFA date for completion of the review set for March 21, 2019,… Read more . . .
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During its second quarter earnings call on July 24, 2018, Eli Lilly announced that it had filed regulatory submissions with the FDA and with the EMA for its intranasal glucagon for the treatment of severe… Read more . . .
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After meeting with the FDA regarding the clinical program for US approval of its Penthrox methoxyflurane inhaler, Medical Developments International (MVP) said that it expects to receive a clinical hold letter from the agency within… Read more . . .
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The FDA has issued a notice that it has reopened the comment period for the “Metered Dose Inhaler and Dry Powder Inhaler Drug Products—Quality Considerations; Draft Guidance for Industry,” which was published in April, 2018.… Read more . . .
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3M Drug Delivery Systems has announced that its Proventil HFA albuterol MDI, which is marketed and distributed by Merck, now includes a top-mounted dose indicator. The FDA approved an sNDA for Proventil HFA with the… Read more . . .
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Oyster Point Pharma has announced that its investigational new drug application for OC-01, a nicotine acetylcholine receptor (nAChR) agonist nasal spray, has been cleared by the FDA. OC-01 and another nAChR nasal spray, OC-02, are… Read more . . .
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October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden
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November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland