The FDA has approved the supplemental biologic license application for Tzield (teplizumab-mzwv), expanding the indication from eight years and older to as young as one year of age… read more.
The European Commission has granted a conditional marketing authorisation for Rezurock (belumosudil) for the treatment of chronic graft-versus-host disease (GVHD) in adults and in children aged 12 years… read more.
NICE(UK): Dupilumab, as an add-on to intranasal corticosteroids, can be used as an option to treat severe chronic rhinosinusitis with nasal polyps in adults if: i) the condition… read more.
A universal respiratory syncytial virus (RSV) immunization program using Beyfortus (nirsevimab) was associated with a statistically significant reduction in RSV-related hospitalizations in the second RSV season among infants… read more.
The FDA has accepted for priority review the supplemental biologic license application (sBLA) for Tzield (teplizumab-mzwv) to expand the current age indication from eight years and above, to… read more.
The European Commission has approved Teizeild (teplizumab) to delay the onset of stage 3 type 1 diabetes (T1D) in adult and pediatric patients eight years of age and… read more.
The European Commission has approved Wayrilz (rilzabrutinib), a novel, oral, reversible, Bruton’s tyrosine kinase (BTK) inhibitor, as a new treatment for immune thrombocytopenia (ITP) in adult patients who… read more.
The Ministry of Health, Labour and Welfare in Japan has granted marketing and manufacturing authorization for Dupixent (dupilumab) for the treatment of bronchial asthma in children aged 6… read more.
The European Commission has approved Dupixent (dupilumab) for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in adult and adolescent patients 12 years and above with inadequate response… read more.
The FDA has accepted for expedited review the supplemental biologics license application (sBLA) for Tzield (teplizumab-mzwv) to delay the progression of stage 3 type 1 diabetes (T1D) in… read more.
NICE (UK): Olipudase alfa is not recommended, within its marketing authorisation, for treating acid sphingomyelinase deficiency (ASMD; Niemann–Pick disease) in people with type AB or type B. This… read more.
The FDA has approved an expanded indication of Sanofi’s quadrivalent meningococcal vaccine MenQuadfi—for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W,… read more.
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