|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.