In the United Kingdom, it is possible to manufacture unusual dose strength or dose combination products ‘off-license’ (called ‘specials’ and usually made in dedicated facilities within hospitals) but these do not address large-scale public need. It might reasonably be argued, therefore, ...
Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult ...
Vijayakrishnan Rousseau, in System on Chip Interfaces for Low Power Design, 2016 Remote Control A remote control (or controller), as the name suggests, is a device that is used to operate, control, or command an associated device wirelessly. The range of a remote control is typically less ...
(FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with standard of care chemotherapy (carboplatin and paclitaxel), foll...
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Biologics License Applicationor “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to ...
Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for the investigational oral Bruton's tyrosine kinase (BTK) inhibitor ibrutinib, for two B-cell malignancy indications: previously treated mantle cell lymphoma (MCL) and previously treated chronic lymphocytic ...
PCL is an FDA-approved polyester for both load-bearing and non-load-bearing tissue engineering applications22. Among the technologies accessible for preparing porous scaffolds with a similar structure to the bone, ScCO2foaming has emerged as an attractive and renewable green technology23. Conventional...
Marketing Authorization Applicationor “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S. Biologics License Applicationor “BLA” means an application requesting permission from the FDA to introduce, or deliver for intro...
exclusive license to develop, manufacture, and commercialize drug products containing difelikefalin for acute pain and/or uremic pruritus in Japan. Maruishi has the right to grant sub-licenses in Japan, which entitles Cara to receive sub-license fees, net of prior payments made by Maruishi to ...