Company Product Description Indication Status
Astrazeneca plc, of Cambridge, U.K. Imfinzi (durvalumab) Monoclonal antibody targeting PD-L1 Locally advanced, unresectable non-small-cell lung cancer An additional dosing option of 1,500 mg every 4 weeks was approved in the EU and U.K.
DBV Technologies SA, of Montrouge, France Viaskin Peanut Epicutaneous patch Peanut allergy Received written responses from the FDA to questions provided in a type A meeting request to discuss the complete response letter; FDA requested a study comparing the existing and modified patches and a 6-month adhesion trial of the modified patch
Gracell Biotechnologies Inc., of Suzhou, China CAR T-cell therapy products Multiple Multiple Company's manufacturing site in Suzhou Industrial Park was granted a medical products manufacturing certificate from the Jiangsu Medical Products Administration 
Pfizer Inc., of New York Xalkori (crizotinib) Tyrosine kinase inhibitor Anaplastic large-cell lymphoma FDA approved the supplemental NDA for use in pediatric patients 1 and older and young adults with relapsed or refractory, systemic anaplastic large-cell lymphoma that is anaplastic lymphoma kinase-positive
The Russian Direct Investment Fund, of Moscow Sputnik V SARS-CoV-2 vaccine COVID-19 prophylaxis Ministry of Health of the Republic of Paraguay approved the vaccine
Steba Biotech SA, of Luxembourg Padeliporfin Impact Vascular-targeted photodynamic therapy  Low-grade and unifocal high-grade upper tract urothelial cancer FDA granted fast track designation


For more information about individual companies and/or products, see Cortellis.