FDA approves Akebia Therapeutics’ Vafseo for anaemia caused by CKD
The approval is supported by the safety and efficacy data from the INNO2VATE programme and post-marketing safety data…
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28 Mar 24
The approval is supported by the safety and efficacy data from the INNO2VATE programme and post-marketing safety data…
27 Mar 24
The FDA approval, following the US FDA Breakthrough Therapy Designation, is based on the results from the Phase…
25 Mar 24
The FDA approval of Opsynvi, a combination of two proven treatments with established efficacy and safety profiles into…
25 Mar 24
The approval was based on the findings from the confirmatory Phase 3 MIRASOL trial in which Elahere treatment…
25 Mar 24
The label expansions are for the prevention of heart attacks and cardiovascular procedures in primary as well as…
22 Mar 24
The FDA approval is supported by the results from EPIDYS, a randomized, double-blind, placebo-controlled 18-month Phase 3 clinical…
22 Mar 24
The positive CHMP opinion is based on results from the ONWARDS phase 3a clinical trial programme
18 Mar 24
Xhance is a drug-device combination product that utilises the Exhalation Delivery System engineered to administer a topical steroid…
15 Mar 24
The FDA has approved Breyanzi to treat adult patients with relapsed or refractory chronic lymphocytic leukemia or small…
15 Mar 24
The approval was based on the results from the Phase 3 RATIONALE 302 study in which Tevimbra indicated…