Company Product Description Indication Status
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.

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