announced today that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar candidate to Prolia® and Xgeva® (denosumab).
About AVT23 AVT23 is a monoclonal antibody and proposed biosimilar to Xolair ® (omalizumab). AVT23 is an investigational compound and has not received regulatory approval in any country. Biosimilarity ...
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Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced a positive opinion has been received from the Committee for Medicinal ...
A key regulatory committee sided against the drug this summer. But an appeal from Eisai appears to have worked, teeing ...
The regulatory application is based on positive results ... (ATTR-CM), which encompasses both wild-type and hereditary forms of the disease. About ATTR Transthyretin amyloidosis (ATTR) is an ...
today announced the submission of a Type II Variation to the European Medicines Agency (EMA) for vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR ...
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and (Nasdaq: BIIB, Corporate headquarters: Cambridge, ...
today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech's proposed biosimilar to Simponi ® (golimumab), a biologic used to ...
announced today that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT03, a proposed biosimilar candidate to Prolia® and Xgeva® (denosumab).
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