Regulatory
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According to Avillion, the FDA has accepted the company’s NDA for AstraZeneca’s PT027 albuterol/budesonide MDI for the treatment of asthma in patients aged 4 and older for review. In March 2018, Avillion announced that it… Read more . . .
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United Therapeutics has announced the FDA’s approval of its NDA for Tyvaso treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). United Therapeutics licensed Treprostinil… Read more . . .
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According to CyanVac subsidiary Blue Lake Biotechnology, the FDA has granted Fast Track designation for the company’s BLB-201 intranasal vaccine against respiratory syncytial virus (RSV) in children under 2 and adults over 60. The vaccine… Read more . . .
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According to Biohaven Pharmaceuticals, the FDA has accepted the company’s NDA for its zavegepant (BHV-3500) calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the treatment of migraine and has set a PDUFA goal date… Read more . . .
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According to Indian generics developer Alembic Pharmaceuticals, the company’s ANDA for a generic version of Sunovion’s Brovana arformoterol tartrate inhalation solution for the treatment of COPD has received final FDA approval. Alembic co-developed the arformoterol… Read more . . .
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Evoke Pharma announced that the FDA has granted new drug product exclusivity for Gimoti metoclopramide nasal spray, giving the company exclusive marketing rights for 3 following the initial approval date. The FDA approved Gimoti for… Read more . . .
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The FDA has granted Breakthrough Therapy designation to Zambon’s CMS I-neb colistimethate sodium for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult patients with chronic P. aeruginosa lung infections, the company said. The FDA… Read more . . .
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Tiziana Life Sciences said that the FDA has issued a Study May Proceed letter allowing Brigham and Women’s Hospital (BWH) to treat an additional eight patients with secondary progressive multiple sclerosis (SPMS) with Tiziana’s intranasal… Read more . . .
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CyanVac subsidiary Blue Lake Biotechnology is planning a Phase 1 trial of its BLB-201 intranasal vaccine against respiratory syncytial virus (RSV) after receiving FDA clearance for its IND, CyanVac said. The Phase 1 trial will… Read more . . .
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According to Ji Xing Pharmaceuticals, Chinese regulators have approved the company’s application for a Phase 3 clinical trial of OC-01 varenicline nasal spray for the treatment of dry eye disease in China. Ji Xing acquired… Read more . . .
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