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.
The FDA has approved Dupixent (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1… read more.
The FDA has approved Merilog (insulin-aspart-szjj) as biosimilar to NovoLog (insulin aspart) from Sanofi for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus…. read more.
New data from three oral presentations, which demonstrated significant clinical benefit with Sarclisa-based quadruplets in newly diagnosed multiple myeloma (NDMM) patients were featured at the 66th American Society… read more.
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the FDA has accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) to treat adults… read more.
The European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one year of age. Specifically, the approval covers children aged… read more.
Positive data from the phase III LIBERTY-CUPID Study C evaluating the investigational use of Dupixent (dupilumab) in biologic-naive patients with uncontrolled chronic spontaneous urticaria (CSU) who receive background… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Kevzara…. read more.
Sanofi advances its ambition to protect all infants from respiratory syncytial virus (RSV) disease with new Beyfortus (nirsevimab) data to be presented at the Infectious Disease Society of… read more.
The European Medicines Agency (EMA) has approved Dupixent (dupilumab) as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils…. read more.
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