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Hikma has secured a complete response letter (CRL) from the FDA on the abbreviated new drug application (ANDA). According to Vectura, the FDA has categorised the CRL as

The safety profile observed in IMvigor211 was consistent with what has been previously observed for Tecentriq.  “While these results are not what we had expected, we believe that

Under the FDA’s accelerated approval regulations, this indication is approved based on tumor response rate and progression-free survival (PFS). Continued approval for this indication may be contingent upon

Post merger, INC Research shareholders are likely to hold nearly 53% stake in the combimned company. inVentiv shareholders will hold the remainder stake. The merger is expected to

The companies are entering into this collaboration based on the growing body of preclinical and clinical evidence that the immune activity of an anti-PD-1 therapy, such as Keytruda,

The multinational, randomized phase 3b study will evaluate a treatment regimen based on the company’s oral, once-daily direct factor Xa-inhibitor edoxaban (known by the brand name LIXIANAKeytruda outside

The study met its primary endpoint with relugolix demonstrating a marked decrease in menstrual blood loss from Week 6 to Week 12 as assessed by a patient-reported outcome

XC001 is a one-time treatment being investigated for improving exercise tolerance in patients who have chronic angina that is refractory to standard medical therapy and not amenable to

Posimir is Durect’s investigational locally-acting and non-opioid analgesic, which is being developed to offer up to three days of continuous pain relief after surgery. Posimir is an investigational