Company Product Description Indication Status
Alnylam Pharmaceuticals Inc., of Cambridge, Mass. Oxlumo (lumasiran) RNAi targeting hydroxyacid oxidase 1 Primary hyperoxaluria type 1 Approved by FDA
Appili Therapeutics Inc., of Halifax, Nova Scotia Avigan tablets (favipiravir) Broad-spectrum antiviral COVID-19 Health Canada cleared start of phase III post-exposure prophylaxis study
Bristol Myers Squibb Co., of New York Opdivo (nivolumab) Anti-PD-1 monoclonal antibody Esophageal squamous cell carcinoma Approved by European Commission for treating adults with unresectable advanced, recurrent or metastatic disease after prior fluoropyrimidine- and platinum-based combination chemotherapy
F-star Therapeutics Ltd., of Cambridge, U.K. FS-222 Bispecific antibody targeting CD137 and PD-L1 Cancer Regulators in Spain authorized CTA for phase I trial
Mustang Bio Inc., of Worcester, Mass. MB-107 and MB-207 Lentiviral gene therapy X-linked severe combined immunodeficiency  European Commission issued positive opinion on orphan designation, which applies to MB-107 for the treatment of newly diagnosed infants between 2 months and 2 years of age and to MB-207 in patients who have been previously treated with hematopoietic stem cell transplantation and for whom retreatment is indicated
Obseva SA, of Geneva Yselty (linzagolix 100 mg and 200 mg; OBE-2109) Oral, once daily, GnRH receptor antagonist Uterine fibroids Submitted MAA to EMA seeking approval for use in management of heavy menstrual bleeding associated with uterine fibroids
Polypid Ltd., of Petah Tikva, Israel D-Plex Prolonged and constant release of broad-spectrum antibiotic doxycycline Surgical site infections FDA granted breakthrough therapy designation for prevention of SSIs in patients undergoing elective colorectal surgery
Viatris Inc., of Pittsburgh Pediatric dolutegravir tablets for oral suspension, 10 mg HIV-1 integrase inhibitor HIV/AIDS Received tentative approval from FDA for formulation to help expand access to children living with HIV/AIDS in low- and middle-income countries; NDA granted under the U.S. President's Emergency Plan for AIDS Relief, which permits products that are not approved for marketing in the U.S. because of patent protection or other marketing restrictions to be distributed in other countries where needed

Notes

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