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Concurrently, the Biologics License Application is a common procedure for blood centres to request permission by US FDA to introduce a biologic product into interstate commerce (21 CFR 601.
Science company Pfizer (NYSE:PFE) said on Thursday that it has filed its Biologics License Application (BLA) with the US Food and Drug Administration (FDA) for review for its vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B.
The United States Food and Drug Administration (FDA) has accepted for review specialty pharmaceutical company, Pharming Group NV's (Euronext Amsterdam: PHARM) supplemental Biologics License Application for its RUCONEST [Recombinant Human C1 Esterase Inhibitor/ conestat alfa], it was reported yesterday.
The US Food and Drug Administration (FDA) has accepted from Novartis' Sandoz division the Biologics License Application submitted under the 351 (k) pathway, for proposed biosimilar, adalimumab, to the reference medicine, Humira, it is reported today.
Netherlands-based Pharming Group, a specialty pharmaceutical company, has submitted a supplemental biologics license application to the US Food and Drug Administration (FDA) for Ruconest [Recombinant Human C1 Esterase Inhibitor/ conestat alfa] for routine prophylaxis to prevent attacks in adult and adolescent patients with hereditary angioedema (HAE), it was reported yesterday.
The US Food and Drug Administration (FDA) has rejected US-based Amgen and UCB's biologics license application for Evenity (romosozumab), intended to treat postmenopausal women with osteoporosis, it was reported on Tuesday.
Upon FDA approval of the biologics license application to market Omr-IgG-am in the United States, FFF will become the exclusive marketing agent and authorized distributor for Omr-IgG-am in the United States for five years.
M2 EQUITYBITES-July 19, 2017-US Food and Drug Administration rejects Amgen and UCB's biologics license application for Evenity
M2 PHARMA-July 5, 2017-BioMarin Pharmaceutical submits Biologics License Application to US FDA for Pegvaliase
M2 EQUITYBITES-July 5, 2017-BioMarin Pharmaceutical submits Biologics License Application to US FDA for Pegvaliase
M2 PHARMA-June 1, 2017-USFDA approves Biologics License Application for Novo Nordisk's REBINYN
M2 EQUITYBITES-November 28, 2016-US FDA provides complete response letter for Green Cross' Biologics License Application for IVIG-SN

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