Once-Daily, Nebulized Bronchodilator Approved for COPD Treatment
The FDA has approved Yupelri inhalation solution for the maintenance treatment of patients with COPD.
All articles by DaHee Han
Epinephrine Inhalation Aerosol Returning to Market as OTC Asthma Inhaler
The new inhalation delivery system no longer includes CFC. It contains hydrofluroalkane (HFA) propellants and also features a built-in spray indicator and metal canister, replacing the glass container seen with the original Primatene Mist.
Lorlatinib Approved for Previously-Treated ALK-Positive Metastatic NSCLC
The FDA has approved Lorbrena (lorlatinib) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC.
FDA-Approved Test Provides Pharmacogenetic Reports Directly to Consumers
The 23andMe Personal Genome Service Pharmacogenetic Reports test can detect 33 variants for multiple genes, corresponding to more than 50 commonly prescribed medications and over-the-counter products.
Pembrolizumab Combination Approved for First-Line Metastatic Squamous NSCLC Treatment
The FDA has approved Keytruda in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of patients with metastatic squamous NSCLC.
Benralizumab Efficacy Maintained in Long-Term Severe Eosinophilic Asthma Study
Results from the extension trial showed a similar safety and tolerability profile for Fasenra as that seen in SIROCCO and CALIMA.
Ofev Shown to Slow Idiopathic Pulmonary Fibrosis Progression Long-Term
The primary objective was to characterize the long-term safety and tolerability of Ofev in patients with IPF; efficacy endpoints included annual rate of decline in forced vital capacity (FVC) calculated over 192 weeks.
Tezepelumab Gets Breakthrough Therapy Designation for Severe Asthma
The designation was based on data from the Phase 2b PATHWAY trial that evaluated 3 doses of tezepelumab as add-on therapy in patients with a history of asthma exacerbations and uncontrolled asthma receiving inhaled corticosteroids/long-acting β-agonist with or without oral corticosteroids and additional asthma controllers vs placebo.
RET Inhibitor Gets Breakthrough Tx Status for NSCLC, Medullary Thyroid Cancer
LOXO-292 is being evaluated in the ongoing Phase 1/2 LIBRETTO-001 clinical trial.
Veta Smart Case, App for Epinephrine Auto-Injectors Now Available
The Smart Case includes electronics and sensors to monitor the proximity, temperature, presence and removal, and expiration of auto-injectors.
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