Sanofi has received marketing authorisation from the European Commission (EC) for Nexviadyme (avalglucosidase alfa) to treat the complete spectrum of infantile-onset Pompe disease (IOPD) and late-onset Pompe disease (LOPD).
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of AbbVie’s Rinvoq (upadacitinib) to treat adult patients with active non-radiographic axial spondyloarthritis (nr‑axSpA).
The European Commission (EC) has approved the extended use of Novartis’ Cosentyx (secukinumab) to treat childhood arthritic conditions.
The US Food and Drug Administration (FDA) has agreed to review Emergent BioSolutions’ Biologics License Application (BLA) for AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted).
The US Food and Drug Administration (FDA) has granted accelerated approval to Novartis’ combination therapy Tafinlar (dabrafenib) + Mekinist (trametinib) to treat solid tumours.
The US Food and Drug Administration (FDA) has approved Ellipses Pharma’s investigational new drug (IND) application for EP0031 (A400) to treat advanced RET-altered cancers.
The European Commission (EC) has authorised a variation of Rhythm Pharmaceuticals’ Imcivree (setmelanotide) to treat patients with mild, moderate or severe renal impairment.
VBI Vaccines has received Orphan Drug Designation from the US Food and Drug Administration (FDA) for VBI-1901 to treat glioblastoma (GBM), a most common primary brain cancer.
AbbVie has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) for atogepant (Qulipta) to support the label expansion to treat chronic migraine in adults.
The US Food and Drug Administration (FDA) has approved AbbVie’s approved Skyrizi (risankizumab-rzaa) for the treatment of Crohn's disease (CD) in adults.
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