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GSK, Vir's COVID-19 antibody sotrovimab wins FDA nod for emergency use
firstwordpharma
May 27, 2021
The FDA on Wednesday granted an emergency-use authorisation to GlaxoSmithKline and Vir Biotechnology's sotrovimab for adults and paediatric patients ages 12 and older who have mild-to-moderate COVID-19 and are at high risk of progressing to severe disease
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TG Therapeutics Announces FDA Acceptance of Biologics License Application for Ublituximab in Combination with Ukoniq (umbralisib) as a Treatment for Patients with Chronic Lymphocytic Leukemia and Smal
drugs
May 26, 2021
TGTX today announced that FDA has accepted the Biologics License Application (BLA) for ublituximab as a treatment for patients with chronic lymphocytic leukemia (CLL) and SLL.
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Samsung Biologics scores large-scale ublituximab manufacturing deal
cphi-online
May 24, 2021
TG Therapeutics secures long-term capacity to meet anticipated demand for promising investigational glycoengineered monoclonal antibody
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US DoJ calls for increased Covid-19 monoclonal antibody production
pharmaceutical-technology
July 27, 2020
The US Department of Justice (DoJ) has said that it will not challenge efforts by drugmakers to share information to scale up the manufacturing of monoclonal antibody treatments for Covid-19.
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CARsgen Therapeutics Receives IND Clearance from the NMPA for AB011 Humanized Claudin18.2 Monoclonal Antibody
biopharmadive
December 10, 2019
CARsgen Therapeutics, a clinical-stage biopharmaceutical company committed to discovering and developing a combined.
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Different Clinical Layouts of Chinese-produced Products for Marching into the Anti-PD-1 Monoclonal Antibody Market
PharmaSources/Xiaoyaowan
July 04, 2019
The marketing of camrelizumab means the beginning of the next stage of competition for layouts centering on multiple new indications.
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A Review of Progress of Immunotherapy Drugs for Hodgkin’s Lymphoma
PharmaSources/Yefenghong
July 03, 2019
The news widespread in the industry that Hengrui has received the pharmaceutical product registration approval for its anti-PD-1 camrelizumab has been confirmed recently. It took 24 days from the beginning of review to the receipt of approval on May 29.
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FDA Approves Evenity
drugs
April 10, 2019
FDA Approves Evenity (romosozumab-aqqg) for the Treatment of Osteoporosis in Postmenopausal Women at High Risk of Fracture
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AgomAb secures funds to support regeneration therapies
pharmaceutical-technology
April 09, 2019
Belgium-based AgomAb Therapeutics has raised funds in a series A round to support the development of molecular therapies for the regeneration of damaged tissues.
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Innovent Announces First Patient Dosed in a Phase IIa Clinical Study of IBI306, an Anti-PCSK9 Monoclonal Antibody
en-cphi.cn
March 21, 2019
Innovent Biologics announced that the first patient has been successfully dosed in a Phase IIa clinical study of IBI306...