Company Product Description Indication Status
Astellas Pharma Inc., of Tokyo Xtandi (enzalutamide) Androgen receptor signaling inhibitor Non-metastatic castration-resistant prostate cancer with high risk of metastasis China's National Medical Products Administration approved the drug
Astrazeneca plc, of Cambridge, U.K. Brilinta (ticagrelor)  P2Y12 receptor antagonist Acute ischemic stroke FDA approved the drug to reduce the risk of stroke
Basilea Pharmaceutica Ltd., of Basel, Switzerland, and Shenzhen China Resources Gosun Pharmaceuticals Co. Ltd., of Shenzhen, China Zevtera (ceftobiprole) Cephalosporin antibiotic Community- and hospital-acquired pneumonia China's National Medical Products Administration approved the drug
Bristol Myers Squibb Co., of New York Opdivo (nivolumab) and Yervoy (ipilimumab) Monoclonal antibodies targeting PD-1 and CTLA-4 First-line metastatic non-small-cell lung cancer FDA approved use of the drugs in combination with two cycles of platinum-based chemotherapy
Lipocine Inc., of Salt Lake City Tlando Testosterone replacement therapy Hypogonadism FDA informed the company that it plans to make a decision on the NDA on or about the week of Nov. 30, 2020
Sarepta Therapeutics Inc., of Cambridge, Mass. SRP-9001 (AAVrh74.MHCK7.micro-dystrophin) Gene therapy expressing micro-dystrophin Duchenne muscular dystrophy After a type C meeting with the FDA, company plans to start the SRP-9001-103 study in 10 patients using the commercial process material later this year
Sedor Pharmaceuticals LLC, of Paoli, Pa. Sesquient (fosphenytoin sodium for injection)  Captisol-enabled Fosphenytoin  Status epilepticus in adult and pediatric patients FDA approved 
Senhwa Biosciences Inc., of Taipei Silmitasertib Casein kinase 2 inhibitor Moderate COVID-19 FDA issued a study may proceed letter for a 20-patient investigator-initiated phase II study

Notes

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