Orphan drugs

EMA recommends 16 medicines for approval, including four cancer drugs

Sixteen medicines have been recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use at its July 2018 meeting.…

EMA recommends six medicines for approval

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended six medicines for approval, including two biosimilars and one orphan medicine.…

EMA recommends five new medicines for approval

The European Medicines Agency Committee for Medicinal Products for Human Use has recommended five medicines for approval at its most recent meeting held 19–22 February 2018.…

EMA recommends seven new medicines for approval

Included in the recommendations by the Committee for Medicinal Products for Human Use were one biosimilar and one orphan medicine…

EMA recommends seven new medicines for approval across the EU

Seven new medicines are being recommended for approval for use across the European Union following a meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use.…

Patient organisations call for faster access to orphan drugs

Faster access to medicines for rare diseases across Europe will help reinforce European competitiveness in the global medicines marketplace, a rare disease patient organisation has said…

Ten new medicines recommended for approval by EMA

The European Medicines Agency Committee for Medicinal Products for Human Use has recommended ten medicines for approval, including one biosimilar and two orphan medicines…

EMA hosts meeting to speed up patient access to new drugs

Easier access to medicines for EU citizens has taken a step forward after a first meeting of the European Medicines Agency (EMA) and European Union healthcare payers.…

Amyotrophic lateral sclerosis treatment approved by FDA

The US Food and Drug Administration has approved the drug edaravone (Radicava, MT Pharma America, Inc.) for the treatment of patients with amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease.…

FDA approves nusinersen for use in rare genetic condition

The first drug approved to treat patients with the potentially fatal genetic disease spinal muscular atrophy has been approved for use in the United States.…