Regulatory

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 was partnering with Pearl Therapeutics on development of PT027; Pearl was acquired by AstraZeneca in 2013. AstraZeneca has an option to … [Read more...] about FDA accepts Avillion’s NDA for PT027 albuterol/budesonide MDI

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 Technosphere from MannKind Corporation in September 2018 and submitted the NDA for Tyvaso DPI in … [Read more...] about FDA approves Tyvaso DPI for the treatment of PAH and PH-ILD

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 is based on an attenuated strain of canine parainfluenza virus (PIV5). In March 2022, Blue Lake announced that the FDA had … [Read more...] about Blue Lake’s intranasal RSV vaccine gets Fast Track designation

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 in the first quarter of 2023. In December 2019, Biohaven announced positive results from a Phase 2/3 pivotal trial of the nasal … [Read more...] about FDA accepts Biohaven’s NDA for intranasal zavegepant for the treatment of migraine

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 inhalation solution with Indian CRO Orbicular Pharmaceutical Technologies. The ANDA approval is … [Read more...] about Alembic gets FDA approval for its arforoterol tartrate inhalation solution

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 had previously granted QIDP and Fast Track designations to the colistimethate sodium powder, which is delivered as a … [Read more...] about Zambon’s CMS I-neb inhaled colistimethate sodium gets Breakthrough Therapy designation