Regulatory
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The US District Court for the Northern District of West Virginia has upheld claims in three patents protecting Symbicort budesonide / formoterol. AstraZeneca sued Mylan (now Viatris) in October 2018, and subsequently 3M (now Kindeva… Read more . . .
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Sorrento Therapeutics said that the FDA has cleared its IND for a Phase 1 study of STI-2099 intranasal neutralizing antibody (CoviDrops) in healthy volunteers and in patients with mild COVID-19. The company said that it… Read more . . .
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According to Oyster Point Pharma, the FDA has accepted the company’s NDA for its OC-01 varenicline nasal spray for the treatment of dry eye disease and has set a PDUFA goal date of October 17,… Read more . . .
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Cipla Limited announced that the FDA has issued final approval of an ANDA for the company’s generic version of GSK’s Imitrex 20 mg sumatriptan nasal spray. Cipla’s sumatriptan nasal spray is an AB-rated generic. Imitrex… Read more . . .
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Glenmark Pharmaceuticals announced that the Ministry of Health of the Russian Federation has approved Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of seasonal and perennial allergic rhinitis, and the company expects to launch the… Read more . . .
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According to Altimmune, the FDA has now cleared the company’s IND for a Phase 1 trial of its AdCOVID intranasal vaccine candidate, and enrollment in the trial is expected to begin within a week. Altimmune… Read more . . .
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According to Janssen, the company’s Spravato esketamine nasal spray has been approved by the EC as an add-on to oral antidepressants for adult patients with major depressive disorder (MDD) “as acute short term treatment, for… Read more . . .
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Lindal Group announced that the Chinese National Medical Product Administration’s (NMPA) Center for Drug Evaluation (CDE) has listed the drug master file (DMF) for Lindal’s 20 mm male MDI metering valve as active following review.… Read more . . .
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The European Commission has approved Chiesi’s Trimbow extrafine beclometasone / formoterol / glycopyrronium MDI for the treatment of asthma in patients who do not have adequate control with ICS/LABA and who have had at least… Read more . . .
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According to AstraZeneca, China’s National Medical Products Administration (NMPA) has approved Symbicort Turbuhaler budesonide / formoterol as a reliever inhaler for the treatment of symptoms of mild asthma in patients age 12 and older. Symbicort Turbuhaler was… Read more . . .
Upcoming Events
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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