Company Product Description Indication Status
Amolyt Pharma SA, of Lyon, France AZP-3601 Targets specific configuration of parathyroid hormone receptor Hypoparathyroidism FDA granted orphan designation
Astellas Pharma Inc., of Tokyo Myrbetriq (mirabegron) tablets Beta 3 adrenoceptor agonist Neurogenic detrusor overactivity FDA accepted for priority review the supplemental NDA seeking approval for use in pediatric patients, 3 and older; PDUFA date is March 28, 2021
Astellas Pharma Inc., of Tokyo Mirabegron for oral suspension Beta 3 adrenoceptor agonist Neurogenic detrusor overactivity FDA accepted for priority review the NDA for use in pediatric patients, 3 and older; PDUFA date is March 28, 2021
Astrazeneca plc, of Cambridge, Mass. AZD-1222 Vaccine COVID-19 Granted emergency use in India, as well as Argentina, Dominican Republic, El Salvador, Mexico and Morocco, for the active immunization of adults
Astrazeneca plc, of Cambridge, Mass. Farxiga (dapagliflozin) SGLT2 inhibitor Chronic kidney disease FDA granted priority review for submission seeking approval to treat new or worsening CKD in adults with and without type 2 diabetes; PDUFA date is during second of 2021
Everest Medicines Ltd., of Shanghai Sacituzumab govitecan-hziy Trop-2 calcium signal transducer inhibitor; topoisomerase I inhibitor Metastatic triple-negative breast cancer Initiated submission of NDA to Health Sciences Authority of Singapore seeking approval for use in patients who have received at least 2 prior therapies for metastatic disease
Everest Medicines Ltd., of Shanghai Sacituzumab govitecan-hziy Trop-2 calcium signal transducer inhibitor; topoisomerase I inhibitor Metastatic urothelial cancer The Center for Drug Evaluation of China’s NMPA approved a clinical trial application to include patients in China as part of phase III Tropics-04 trial
Inventiva SA, of Daix, France Lanifibranor  Small-molecule PPAR agonist Nonalcoholic steatohepatitis Following end-of-phase II meeting with FDA and the scientific advice letter from EMA, plans to seek U.S. accelerated approval and EU conditional approval based on 72-week histology analysis; phase III study expected to use primary composite endpoint combining NASH resolution and fibrosis improvement; Native3 study expected to start in first half of 2021
Moderna Inc., of Cambridge, Mass. mRNA-1273 mRNA vaccine COVID-19 European Commission granted conditional marketing authorization
Redhill Biopharma Ltd., of Tel Aviv, Israel RHB-204 RNA polymerase inhibitor Pulmonary nontuberculous mycobacteria disease caused by Mycobacterium avium complex FDA granted fast track designation
Russian Direct Investment Fund, of Moscow Sputnik V COVID-19 vaccine COVID-19 Regulators in Bolivia registered vaccine under emergency use authorization procedure
Stealth Biotherapeutics Corp., of Boston Elamipretide Cardioprotectant Cardiomyopathy in Barth syndrome Plans to meet with FDA’s Division of Cardiology and Nephrology regarding upcoming NDA submission

Notes

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