Regulatory
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Padagis (formerly Perrigo’s generic prescription pharmaceutical business) has announced the launch of its generic version of Zomig zolmitriptan nasal spray for the treatment of migraine headaches in patients aged 12 and older. Altaris acquired Padagis… Read more . . .
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According to Liquidia, the FDA has tentatively approved the company’s NDA for its Yutrepia (LIQ861) treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH). The FDA had previously issued a complete response letter to… Read more . . .
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According to EffRx Pharmaceuticals, Swissmedic has approved Bronchitol inhaled dry powder mannitol as an add-on to other medications for the treatment of cystic fibrosis in patients 6 years old and older. EffRx acquired Swiss rights… Read more . . .
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According to TFF Pharmaceuticals, Health Canada has issued a no objection letter regarding a Phase 1 clinical trial of TFF’s dry powder inhaled niclosamide that will evaluate 0.5, 2, and 6 mg doses in healthy volunteers… Read more . . .
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United Therapeutics said that the FDA has issued a complete response letter regarding the company’s NDA for Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung… Read more . . .
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According to Oyster Point Pharma, the FDA has approved the company’s Tyrvaya (OC-01) varenicline nasal spray for the treatment of dry eye disease, and Oyster Point expects to launch the nasal spray in November 2021.… Read more . . .
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Bayer HealthCare and Meda Pharmaceuticals have filed a patent infringement suit against Apotex after Apotex submitted an ANDA for a generic version of Astepro Allergy azelastine hydrochloride nasal spray, 0.15%. The FDA approved Bayer’s NDA… Read more . . .
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Glenmark Pharmaceuticals said that its Ryaltris olopatadine / mometasone furoate nasal spray for the treatment of seasonal and perennial allergic rhinitis has received final marketing approval in 13 countries in Europe and the UK. Earlier this… Read more . . .
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BreatheSuite announced that the FDA has cleared the company’s disposable BreatheSuite MDI device, which attaches to the top of a standard metered dose inhaler canister to provide inhaler usage monitoring and feedback to the patient… Read more . . .
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According to Ampio Pharmaceuticals, the Drugs Controller General of India (DCGI) has approved the protocol for AP-019 Phase 2 trial of the company’s inhaled Ampion biologic for the treatment of respiratory distress caused by COVID-19. Ampio announced in… Read more . . .
Upcoming Events
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December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
May 12-13: USP Joint Workshop: Quality and Product Performance Testing of Orally Inhaled and Nasal Drug Products, Rockville, MD, USA
June 30: RespireX 2027, Boston, MA, USA