EMA begins evaluating the application for a booster dose of Comirnaty® in adults to be given six months after the second dose.
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Bimzelx® (bimekizumab) becomes the first medicine to be evaluated and recommended through NICE’s new Expedited Low-Risk Fast Track Appraisal.
Experts suggest membrane-based technologies could become a vital component in end-to-end intensified bioprocesses for monoclonal antibodies.
The EMA’s drug safety committee (PRAC) reviewed COVID-19 vaccine risks and issued a new safety signal for Imbruvica with rituximab.
The new general chapter, Balances for analytical purposes (2.1.7), sets out clear requirements for equipment that is the cornerstone of every analytical procedure in the European Pharmacopoeia.
The FDA reached the milestone of approving more than 100 generic drug applications with a Competitive Generic Therapy designation.
Research shows magnetic beads coupled with protein A can clarify very high cell concentrations and capture antibodies with high efficiency in a single step.
The European Commission (EC) approved Ultomiris for children and adolescents with paroxysmal nocturnal haemoglobinuria (PNH).
Pfizer’s RENOIR Phase III trial will evaluate the efficacy, immunogenicity and safety of their respiratory syncytial virus (RSV) vaccine.
BioNTech will evaluate mRNA vaccine manufacturing facilities in Rwanda and Senegal to support vaccine supply in African states.
Janssen announced US FDA approval of Invega Hayfera, the first and only twice-yearly treatment for adults with schizophrenia.
Fostamatinib significantly reduced serious adverse effects and risk of death in hospitalised COVID-19 patients, shows Phase II study.
Review shows nuclear magnetic resonance (NMR) spectroscopy has the potential to enhance biologic drug formulation, optimising delivery and bioavailability.
The investigational vaccine tested in sub-Saharan Africa posed no safety concerns but did not provide sufficient HIV protection.
The UK approval follows a Phase III study in which Leqvio® (inclisiran) reduced low-density lipoprotein cholesterol (LDL-C) by 55 percent.