FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients
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Data show 37% reduction in risk of disease progression or death in men with metastatic castration-resistant prostate cancer treated with TALZENNA plus XTANDI
Sirolimus Tablets had annual sales of USD 69 million in the United States (IQVIA MAT Dec. 2022)
The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022
According to IQVIA sales data for the 12-month period ending December 2022, the Onglyza Tablets, 2.5 mg and 5 mg market achieved annual sales of approximately US $122.3 million
Durvalumab in combination with chemotherapy is indicated for the treatment of patients with locally advanced or metastatic biliary tract cancer
According to GlobalData’s analyst consensus forecast, OTX-2002 is projected to have the highest revenue by 2028, with sales of $1.6 billion during that year
USFDA has issued an Establishment Inspection Report (EIR) for Piramal Pharma Limited manufacturing facility located at Lexington (Kentucky, USA) and the inspection has now been successfully closed by the USFDA
The investment enhances Lonza’s capabilities and flexibility to support both clinical and commercial supply and will play a key role in meeting the growing market demand for bioconjugates
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya
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