|3DBio Therapeutics Inc., of New York||Aurinovo||3D-bioprinted tissue seeded with patient's own auricular cartilage cells||Reconstruction of outer ear in microtia||FDA granted rare pediatric disease designation for drug-device combination product|
|Amgen Inc., of Thousand Oaks, Calif.||Avsola (infliximab-axxq)||Biosimilar to Remicade (infliximab)||Rheumatoid arthritis and other autoimmune disorders||Approved by FDA|
|Aptevo Therapeutics Inc., of Seattle||APVO-436||Bispecific antibody||Acute myelogenous leukemia||FDA granted orphan designation|
|Bristol-Myers Squibb Co., of Princeton, N.J.||Reblozyl (luspatercept-aamt)||Erythroid maturation agent||Anemia in adults with very low- to intermediate-risk myelodysplastic syndromes||Notified by FDA that supplemental BLA will not be reviewed by Oncology Drugs Advisory Committee set for Dec. 18, 2019; sBLA seeking approval for use in patients who have ring sideroblasts and require red blood cell transfusions|
|Intellipharmaceutics International Inc., of Toronto||Aximris XR||Abuse-deterrent oxycodone hydrochloride extended-release tablets||Pain management||Joint meeting of FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee will discuss NDA during Jan. 15, 2019, meeting|
|Ipsen SA, of Paris||Palovarotene||Small-molecule retinoic acid receptor gamma agonist||Fibrodysplasia ossificans progressiva and multiple osteochondromas||FDA placed partial clinical hold for pediatric population under age 14 for studies conducted under IND120181 and IND135403; hold follows safety reports of early growth plate closure in pediatric patients with FOP treated with palovarotene; studies are allowed to continue in patients 14 and older|
|Y-mabs Therapeutics Inc., of New York||Omburtamab||Targets tumors expressing B7-H3||CNS/leptomeningeal metastases from neuroblastoma||EMA agreed to company’s proposed pediatric investigation plan|
For more information about individual companies and/or products, see Cortellis.