The European medicines watchdog recommended approving AstraZeneca’s treatments for a form of heart failure and a lung disorder, the British drugmaker said.
The U.S. Food and Drug Administration approved a new indication for GlaxoSmithKline plc and Innoviva Inc.’s Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to the product’s current license for use in patients with chronic obstructive pulmonary disease (COPD).
The U.S. Food and Drug Administration gave the green light to AstraZeneca for a new chronic obstructive pulmonary disease (COPD) treatment, Breztri Aerosphere.
Boston-based resTORbio announced topline data from the PROTECTOR 1 Phase III trial of RTB101 in clinically symptomatic respiratory illness (CSRI) in adults age 65 and older.
The U.S. Food and Drug Administration declined to approve AstraZeneca Plc’s combination therapy to treat smoker’s lung.
The FDA greenlit GlaxoSmithKline’s Nucala (mepolizumab) for treating severe eosinophilic asthma in children as young as 6 years.
The U.S. Food and Drug Administration approved Regeneron Pharmaceuticals Inc. and Sanofi SA’s drug Dupixent to treat nasal polyps, marking the third major use for the injectable medicine.
Following a setback in a chronic obstructive pulmonary disease (COPD) clinical trial in August, AstraZeneca unveiled data from a separate trial that showed the triple combination therapy PT010 outperformed dual-therapy rivals eight of nine times.
GlaxoSmithKline said U.S. health authorities asked for more information about the company’s Nucala drug for use in combating chronic obstructive pulmonary disease (COPD).
Collaboration partners Evotec AG and Haplogen GmbH announced that Haplogen will enter into a multi-year drug discovery and development deal with Bayer AG to focus on pulmonary diseases.