Covid has spurred regulators towards a more agile and innovation-supporting future, paving the way for new opportunities for all. If life sciences companies embrace a …
If there’s one thing 2020 taught the world, it’s that the road ahead is ever-changing. Given the Delta variant on the rise and the significant …
The Prescribing Information, Labeling, and any other materials used for the promotion of Drug Products for their approved indication, or intended purpose of use, are …
The US Food and Drug Administration (FDA) has approved Exelixis’ Cabometyx (cabozantinib) for the treatment of patients with previously treated radioactive iodine-refractory differentiated thyroid cancer …
The U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be …
Jazz Pharmaceutical’s Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of idiopathic hypersomnia in adults has been granted US Food and …
The US Food and Drug Administration (FDA) has approved a combination of MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) plus Eisai’s Lenvima (lenvatinib) for the first-line treatment …
The US Food and Drug Administration (US) has handed AstraZeneca a complete response letter (CRL) regarding its anaemia drug roxadustat. AZ had submitted a new …
The U.S. Food and Drug Administration today approved a magnetic device system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. The …
STA Pharmaceutical Co., Ltd., (WuXi STA), a subsidiary of WuXi AppTec, announces that its Active Pharmaceutical Ingredient (API) manufacturing facility at Jinshan (Shanghai, China) has successfully …
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