|Baudax Bio Inc., of Malvern, Pa.||Anjeso (meloxicam injection)||24-hour, intravenous COX-2 preferential nonsteroidal anti-inflammatory||Management of moderate or severe pain||Approved by FDA for use alone or in combination with other non-NSAID analgesics|
|Biomarin Pharmaceutical Inc., of San Rafael, Calif.||Valoctocogene roxaparvovec||AAV5 gene therapy||Hemophilia A||FDA accepted the BLA and granted priority review, setting PDUFA date of Aug. 21, 2020; FDA informed company no advisory meeting is currently planned|
|Bristol-Myers Squibb Co., of Princeton, N.J.||Opdivo (nivolumab)||Anti-PD-1 antibody||Esophageal cancer||Japan’s Ministry of Health, Labor and Welfare approved for use in patients with unresectable advanced or recurrent disease that has progressed following chemotherapy|
|DBV Technologies SA, of Montrouge, France||Viaskin Peanut||Epicutaneous immunotherapy||Peanut allergy||FDA will hold Allergenic Products Advisory Committee meeting May 15, 2020, to discuss BLA|
For more information about individual companies and/or products, see Cortellis.