Regulatory
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According to Medical Developments International (MVP), the FDA has lifted a clinical hold on MVP’s Penthrox methoxyflurane inhaler and, as a result, MVP is now preparing a Phase 3 trial of Penthrox for trauma pain… Read more . . .
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Sorrento Therapeutics announced that the FDA has given the company the okay to move ahead with a Phase 1 trial of its Covishield (STI-9199) intranasal antibody cocktail in healthy volunteers. According to Sorrento, in vitro… Read more . . .
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According to Armata Pharmaceuticals, the FDA has cleared the company’s IND for a clinical trial of AP-PA02, an inhaled phage cocktail, in non-cystic fibrosis bronchiectasis (NCFB), and the company plans to initiate a Phase 2… Read more . . .
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Glenmark Pharmaceuticals and SaNOtize have announced the approval of FabiSpray nitric oxide nasal spray (NONS) for the treatment of COVID-19 by the Drugs Controller General of India (DCGI) and the launch of the nasal spray… Read more . . .
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The FDA has now fully approved Lupin’s ANDA for its generic version of Sunovion’s Brovana arformoterol tartrate inhalation solution for the treatment of COPD. Brovana was approved by the FDA in 2006. The agency tentatively… Read more . . .
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Celltrion Group announced that it has submitted an IND application for a Phase 3 trial of an inhaled COVID-19 antibody cocktail for the treatment of mild-to-moderate COVID-19. In July 2021, Celltrion announced that it had… Read more . . .
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Levo Therapeutics announced that the FDA has issued a complete response letter to the company’s NDA for LV-101 intranasal carbetocin for the treatment of excessive hunger and anxiety associated with Prader-Willi syndrome (PWS). The FDA… Read more . . .
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Glenmark Pharmaceuticals announced that it has received FDA approval of its NDA for Ryaltris olopatadine hydrochloride / mometasone furoate nasal spray for the treatment of seasonal allergic rhinitis in patients aged 12 and older. The… Read more . . .
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Israeli biopharm SpliSense has announced that both the FDA and the EMA have granted orphan drug designation to the company’s SPL84-23-1 inhaled antisense oligonucleotide (ASO) for the treatment of cystic fibrosis associated with the 3849+10… Read more . . .
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According to Iliad Biotechnologies, the FDA has granted Fast Track designation to Iliad’s BPZE1 live attenuated intranasal vaccine against pertussis (whooping cough), which is in Phase 2 development as a booster vaccine to prevent both… Read more . . .
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