Company Product Description Indication Status
Airway Therapeutics Inc., of Cincinnati AT-100 Recombinant surfactant protein D Bronchopulmonary dysplasia FDA accepted the IND for a phase Ib study to confirm the feasibility of intra-tracheal administration of AT-100 and its safety and tolerability profile in very preterm babies
Astellas Pharma Inc., of Tokyo Myrbetriq and Myrbetriq Granules (mirabegron) Beta 3 adrenoceptor agonist Neurogenic detrusor overactivity FDA approved the new indication
Astellas Pharma Inc., of Tokyo, and Seagen Inc., of Bothell, Wash. Enfortumab vedotin Antibody-drug conjugate targeting Nectin-4 Locally advanced or metastatic urothelial cancer following treatment with a PD-1/L1 inhibitor and platinum-based therapies EMA accepted the MAA
Astellas Pharma Inc., of Tokyo Xtandi (enzalutamide) Androgen receptor signaling inhibitor Metastatic hormone-sensitive prostate cancer EMA's Committee for Medicinal Products for Human Use adopted a positive opinion for the expanded indication
Biontech SE, of Mainz, Germany, and Pfizer Inc., of New York Comirnaty mRNA based vaccine COVID-19 prophylaxis EMA approved the manufacturing of the drug product at Biontech's Marburg facility; first batches of vaccine manufactured at the site are expected to be delivered in the second half of April; EMA also approved the storage of the vaccine at -25°C to -15°C for a total of 2 weeks
Camurus AB, of Lund, Sweden Buvidal (buprenorphine) Prolonged release opioid partial agonist Opioid dependence EMA's Committee for Medicinal Products for Human Use adopted a positive opinion for the 160-mg monthly dose
Diurnal Group plc, of Cardiff, U.K. Efmody (hydrocortisone modified-release hard capsules) Corticosteroid Congenital adrenal hyperplasia EMA's Committee for Medicinal Products for Human Use adopted a positive opinion for the drug
Gilead Sciences Inc., of Foster City, Calif. Sacituzumab govitecan-hziy Antibody-drug conjugate targeting Trop-2 Unresectable locally advanced or metastatic triple-negative breast cancer EMA validated the MAA
Glaxosmithkline plc, of London, and Vir Biotechnology Inc., of San Francisco VIR-7831 (GSK-4182136) Monoclonal antibody targeting SARS-CoV-2 Mild to moderate COVID-19 Submitted an application for emergency use authorization to the FDA
Idorsia Pharmaceuticals Ltd., of Allschwil, Switzerland, and Johnson & Johnson, of New Brunswick, N.J. Ponvory (ponesimod) Sphingosine-1-phosphate receptor 1 modulator Relapsing forms of multiple sclerosis EMA's Committee for Medicinal Products for Human Use adopted a positive opinion for the drug
Roche Holding AG, of Basel, Switzerland Tecentriq (atezolizumab) Monoclonal antibody targeting PD-L1 First-line metastatic non-small-cell lung cancer with high PD-L1 expression and no EGFR or ALK mutations EMA's Committee for Medicinal Products for Human Use adopted a positive opinion for the expanded indication
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan TAK-003 Live-attenuated dengue serotype 2 virus Dengue prophylaxis EMA accepted the application for approval through the EU-M4all procedure
Verastem Inc., of Boston Copiktra (duvelisib) Dual phosphoinositide-3 kinase delta/gamma inhibitor Relapsed or refractory chronic lymphocytic leukemia and refractory follicular lymphoma EMA's Committee for Medicinal Products for Human Use adopted a positive opinion for the drug
Vertex Pharmaceuticals Inc., of Boston Kaftrio (ivacaftor/tezacaftor/elexacaftor) Combination of CFTR potentiator and 2 CFTR correctors  Cystic fibrosis patients ages 12 and older who have 1 copy of the F508del mutation and a gating or residual function mutation EMA's Committee for Medicinal Products for Human Use adopted a positive opinion for the expanded indication

Notes

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