|Astellas Pharma Inc., of Tokyo||Xtandi (enzalutamide)||Androgen receptor signaling inhibitor||Metastatic castration-resistant prostate cancer after failure of androgen deprivation therapy||National Medical Products Administration in China approved the NDA|
|Celltrion Healthcare Co. Ltd., of Incheon, South Korea||Remsima SC||Subcutaneous biosimilar of infliximab||Rheumatoid arthritis||European Commission approved the drug|
|Evofem Biosciences Inc., of San Diego||Amphora||Vaginal pH regulator||Prevention of pregnancy||NDA resubmitted to the FDA|
|Knight Therapeutics Inc., of Montreal, and Therapeuticsmd Inc., of Boca Raton, Fla.||Bijuva||Estradiol and progesterone||Moderate to severe vasomotor symptoms associated with menopause||New drug submission accepted for review by Health Canada|
|Merck & Co. Inc., of Kenilworth, N.J.||Keytruda (pembrolizumab)||Monoclonal antibody targeting PD-1||First-line metastatic squamous non-small-cell lung cancer||National Medical Products Administration in China approved the drug in combination with carboplatin and paclitaxel|
|Prokarium Ltd., of London||Entervax||Bivalent vaccine against enteric fever||Enteric fever prophylaxis||Clinical trial authorization accepted by the U.K. Medicines and Healthcare products Regulatory Agency; study to begin dosing in the first quarter of 2020|
For more information about individual companies and/or products, see Cortellis.