news
CHMP meeting highlights: January 2024
In its first meeting of 2024, the CHMP recommended a generic medicine for schizophrenia and refused a marketing authorisation (MA) for geographic atrophy.
List view / Grid view
EMA's Committee for Medicinal Products for Human Use (CHMP)
news
EMA human medicines committee (CHMP) highlights, November 2022
The Committee for Medicinal Products for Human Use (CHMP)’s November meeting consisted of approval recommendations for four medicines, including a biosimilar for osteoporosis and a new COVID-19 vaccine.
news
CHMP meeting highlights – July 2022
At its July meeting, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended 11 medicines for approval and extended the indication of six more, including Imvanex for the prevention of monkeypox.
news
Pilot scheme to analyse raw trial data launched by EMA
The pilot will assess whether analysing raw clinical trial data is beneficial to regulatory decision making on marketing authorisation and post-authorisation applications.
news
EMA’s human medicines committee (CHMP) May 2022 meeting highlights
The latest meeting saw EMA’s human medicines committee (CHMP) recommend the approval of nine new medicines, refuse two biosimilar medications and recommend extensions of therapeutic indication for six medicines.
news
EC approves Lorviqua® (lorlatinib) as first-line lung cancer treatment
Lorviqua® monotherapy approved as first-line advanced non-small cell lung cancer therapy based on promising Phase III trial results.
news
EMA recommends GSK’s Xevudy for the treatment of COVID-19
The EMA has recommended granting marketing authorisation for the use of Xevudy (sotrovimab) to treat COVID-19 in adults and adolescents.
news
Pfizer’s Paxlovid™ can be used for the treatment of COVID-19, says EMA
New European Medicines Agency advice states Paxlovid™ can be used to treat those at high risk of developing severe COVID-19 symptoms.
news
Forxiga approved in EU for chronic kidney disease treatment
Forxiga’s approval, based on unprecedented Phase III data, is the most significant advancement in chronic kidney disease (CKD) treatment in over 20 years.
news
EMA recommends approving Spikevax COVID-19 vaccine for adolescents
Based on new clinical results, the EMA is recommending Moderna’s Spikevax COVID-19 vaccine be approved for use in children aged 12 to 17 years.
news
EMA human medicines committee meeting highlights, June 2021
Drugs recommended for approval by the European Medicines Agency’s human medicines committee included a gene therapy and two generics, among five others.
news
EMA recommends first COVID-19 vaccine for children aged 12 to 15
The EMA is recommending that the Comirnaty® COVID-19 vaccine’s indication be extended to include children aged 12 to 15 years.
news
Europe approves Ponvory (ponesimod) for multiple sclerosis
The European Commission has approved once daily oral Ponvory (ponesimod) for the treatment of relapsing multiple sclerosis in adult patients.
news
EMA’s human medicines committee (CHMP) meeting highlights, May 2021
In its latest meeting the CHMP recommended eight medications for approval, 17 medicines for indication extension and concluded reviews of two COVID-19 treatments.
news
EMA begins rolling reviews for a COVID-19 therapeutic and a vaccine
The European Medicines Agency (EMA) has initiated a rolling reviews of Vero Cell, an inactivated COVID-19 vaccine, and sotrovimab, a monoclonal antibody.
