Regulation

US FDA grants priority review to Eisai’s BLA for lecanemab

The US Food and Drug Administration (FDA) has granted priority review for Eisai’s biologics license application (BLA) under the accelerated approval pathway, for lecanemab to treat early Alzheimer’s Disease (AD)

Janssen secures FDA breakthrough designation for myeloma therapy

The Janssen Pharmaceutical Companies of Johnson & Johnson has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for talquetamab to treat relapsed or refractory multiple myeloma in adult patients.

Sanofi receives marketing authorisation from EC for Pompe disease therapy

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).

EMA’s CHMP recommends approval for AbbVie’s axial spondyloarthritis therapy

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).

EC approves Novartis’ Cosentyx to treat arthritis in children

The European Commission (EC) has approved the extended use of Novartis’ Cosentyx (secukinumab) to treat childhood arthritic conditions.

FDA accepts Emergent BioSolutions’ anthrax vaccine candidate for review

The US Food and Drug Administration (FDA) has agreed to review Emergent BioSolutions’ Biologics License Application (BLA) for AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted).

FDA approves Novartis’ Tafinlar + Mekinist combination therapy

The US Food and Drug Administration (FDA) has granted accelerated approval to Novartis’ combination therapy Tafinlar (dabrafenib) + Mekinist (trametinib) to treat solid tumours.

FDA approves Ellipses’ application for advanced RET-altered cancer treatment

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.

EC approves variation of Rhythm’s Imcivree to treat renal impairment patients

The European Commission (EC) has authorised a variation of Rhythm Pharmaceuticals’ Imcivree (setmelanotide) to treat patients with mild, moderate or severe renal impairment.