Amgen announced new data from the pivotal NAVIGATOR Phase 3 trial demonstrating that tezepelumab reduced exacerbations and improved lung function and nasal symptoms in patients with severe, uncontrolled asthma and comorbid nasal polyps.
The U.S. Food and Drug Administration approved Merck’s Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older.
Valneva SE was awarded Breakthrough Therapy Designation for the company’s single-shot chikungunya vaccine candidate, VLA1553, by the U.S. Food and Drug Administration.
The U.S. Food and Drug Administration accepted for priority review Pfizer Inc.’s Biologics License Application (BLA) for the 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, as submitted for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes in the vaccine in adults ages 18 years and older.
The U.S. Food and Drug Administration granted various designations for Sanofi’s avalglucosidase alfa for Pompe disease, Sanofi’s rilzabrutinib for immune thrombocytopenia, and ViiV Healthcare’s cabotegravir for HIV prevention.
The U.S. Food and Drug Administration approved Deciphera Pharmaceuticals Inc.’s Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor who have received prior treatment with 3 or more kinase inhibitors, including imatinib.
The U.S. Food and Drug Administration approved Incyte’s Pemazyre (pemigatinib), a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement as detected by an FDA-approved test.
Following positive Phase II data earlier in 2020, Acceleron Pharma’s experimental pulmonary arterial hypertension (PAH) treatment sotatercept won Breakthrough Therapy designation from the U.S. Food and Drug Administration.
While COVID-19 dominates headlines as the virus has spread across the globe and the pharmaceutical industry has marshaled its forces to develop therapies and diagnostics against the disease, BioSpace takes a look at key industry news not related to the coronavirus.
The U.S. Food and Drug Administration granted Eli Lilly and Company and Incyte Corporation Breakthrough Therapy designation for baricitinib for alopecia areata (AA).
