New subgroup analysis from Phase III ARASENS trial shows that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel increased overall survival (OS)
The new sterile filling line meets cGMP aseptic filling regulatory requirements
New manufacturing facility dedicated to the production of active pharmaceutical ingredients (APIs) and high potency active pharmaceutical ingredients (HPAPIs)
Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States
Fluor is providing architectural and engineering services and procuring equipment for the new 275,000 square-foot manufacturing facility that will house two manufacturing lines to double manufacturing capability
FDA also accepts a separate supplemental application to extend prophylaxis with PREVYMIS to 200 days in certain HSCT recipients
The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022
Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival
The partnership is announced at Aero India 2023, Bangalore
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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
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