Regulatory
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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reopened the comment period for the “Metered Dose Inhaler and Dry Powder Inhaler Drug Products—Quality Considerations; Draft Guidance for Industry,” which was published in April, 2018.… Read more .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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According to Impel NeuroPharma, the FDA has given the company a notice to proceed with clinical study of INP101 intranasal dihydroergotamine (DHE) for the treatment of acute migraine. A Phase 3 study is expected to… Read more . . .
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Canadian biotech Arch Biopartners has announced that it will put an ongoing Phase 1 safety study of its AB569 ethylenediaminetetraacetic acid (EDTA)/sodium nitrite bactericidal inhalation solution on hold and will ask the FDA for a… Read more . . .
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Novus Therapeutics said that it recently had a Type C meeting with the FDA regarding its OP-02 intranasal dipalmitoylphosphatidylcholine (DPPC)/cholesteryl palmitate (CP) suspension for the treatment of otitis media and has received confirmation of its… Read more . . .
Upcoming Events
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May 10-May 14: RDD 2026, Phoenix, AZ, USA
May 15-May 16: ATS Respiratory Innovation Summit 2026, Orlando, FL, USA
May 17-May 20: ATS International Conference 2026, Orlando, FL, USA
June 10: SMI.London 2026, London, UK
July 13-July 16: 2026 ISAM Congress, Taipei, Taiwan