NHS England have approved the use of cannabis-based medicines for the first time. Epidyolex can now be prescribed to children with severe epilepsy syndromes and Sativex can be prescribed to individuals with multiple sclerosis.
Browsing: drug approval
Chinese pharmaceutical firm, Shanghai Green Valley Pharmaceuticals, has gained conditional approval from the country’s regulatory agency for oligomannate as a treatment for mild-to-moderate Alzheimer’s disease.
GW Pharmaceuticals announced the approval of EPIDIOLEX® (cannabidiol) oral solution as the first plant-derived cannabinoid prescription medication.
Aimovig® (erenumab) has received a positive opinion from the CHMP for migraine, steering the way towards a marketing authorization from the EMA.
Novartis and Amgen have announced that Aimovig® has been approved by the US FDA for the preventive treatment of migraine in adults.
The US FDA has issued a refusal-to-file against a key multiple sclerosis drug – ozanimod – due to insufficient data for one of the most important pipeline assets of Celgene.
Balovaptan, a molecule being developed by Roche for autism spectrum disorder, has been given FDA approval in order to accelerate its development.
Ocrelizumab has been licensed by EU regulators as a therapy for multiple sclerosis, the first ever drug to be approved for the primary progressive form of the disease.
Zebinix (eslicarbazepine acetate) has received market authorization as a once-daily monotherapy in adults with newly diagnosed partial-onset epilepsy.
Probuphine, the first buprenorphine implant designed for the maintenance treatment of opioid dependence has been approved by the U.S. FDA.