Company Product Description Indication Status
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

Notes

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

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