Company Product Description Indication Status
Bristol Myers Squibb Co., of New York, and Exelixis Inc., of Alameda, Calif. Opdivo (nivolumab)/Cabometyx (cabozantinib) Monoclonal antibody targeting PD-1/kinase inhibitor Advanced renal cell carcinoma European Commission approved the combination
Diurnal Group plc, of Cardiff, U.K. Efmody (hydrocortisone modified-release hard capsules) Corticosteroid Congenital adrenal hyperplasia Company withdrew its application for maintenance of orphan drug designation in Europe because pursuing the designation would likely cause a significant delay in the European commercial launch
Elsalys Biotech SA, of Lyon France Leukotac (inolimomab) IL-2 receptor alpha subunit inhibitor Acute cortico-resistant or corticosteroid-dependent graft-vs.-host disease The French National Agency for the Medicines and Health Products Safety renewed the temporary authorization for use
Fibrogen Inc., of San Francisco Pamrevlumab Monoclonal antibody targeting connective tissue growth factor Duchenne muscular dystrophy FDA granted rare pediatric disease designation
Glaxosmithkline plc, of London, and Vir Biotechnology Inc., of San Francisco VIR-7831 (GSK-4182136) Monoclonal antibody targeting SARS-CoV-2 COVID-19 not requiring oxygen supplementation and at high risk of progressing to severe COVID-19 EMA started review under Article 5(3) of Regulation 726/2004
Illuminare Biotechnologies Inc., of New York Illuminare-1 Myelin binding agent Visualization and delineation of nerve structures FDA cleared the IND for a phase I study using the drug during robot-assisted radical prostatectomy
Kintor Pharmaceutical Ltd., of Suzhou, China GT-20029 Degrades the androgen receptor via the E3 ubiquitin ligase pathway Acne and androgenetic alopecia National Medical Products Administration in China approved the start of clinical trials
Mitochem Therapeutics Inc., of Charleston, S.C. MC-16 Regulates pro-survival and antioxidant pathways Retinitis pigmentosa FDA granted orphan drug designation

Notes

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