Vertex’s Orkambi receives EC approval
Orkambi is an oral treatment for very young children that combines both lumacaftor and ivacaftor
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Tag: EC
European Commission green lights Servier’s Tibsovo
Treatment concerns patients with IDH1-mutated acute myeloid leukaemia and IDH1-mutated cholangiocarcinoma
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European Commission approves pharma trio’s Ranivisio
Therapy is a biosimilar of Lucentis which treats several serious retinal diseases across the European Union
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EC approves Janssen T-cell therapy for multiple myeloma treatment
Approval provides another step forward in transforming multiple myeloma outcomes and eliminating the disease
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EC approval for post-steroid graft-versus-host treatment
Jakavi treats a potentially life-threatening condition which often effects transplant patients
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AZ seals deal with EC for coronavirus vaccine supply
Up to 400 million doses of AZD1222 will be supplied to EU member states under the deal
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UK’s MHRA allows early access to lumasiran for ultra-rare disease
Lumasiran targets primary hyperoxaluria type 1 (PH1), which affects just around 90 people in the UK and one to three individuals per million in Europe
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European approval for Teva’s migraine drug Ajovy
The drug is a pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month.
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FDA, EMA and EC sign new confidentiality commitment
The US Food and Drug Administration can now share non-public and commercially confidential information, including trade secrets relating to medicines inspections, with EU regulators after the parties signed a new commitment.
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EU clears J&J’s Actelion buy, with conditions
The European Commission has issued a conditional green light for Johnson & Johnson’s planned $30 billion purchase of Actelion, laying out the commitments it feels are necessary to ensure that clinical development of the firms’ innovative insomnia drugs will not be adversely affected by the merger.
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EC further expands use of Novartis’ Votubia
The European Commission has expanded the approved uses of Novartis’ Votubia to include adjunctive treatment of patients aged two years and older whose refractory partial-onset seizures, with or without secondary generalisation, are associated with tuberous sclerosis complex.
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- Storm Therapeutics and AlidaBio launch collaboration to advance RNA‑targeting cancer therapies
- Excellence adventure
- MHRA approves Nucala for eosinophilic COPD in adults on triple therapy
- Bial launches new sublingual Parkinson’s treatment in UK
- Acesion Pharma launches phase 2 trial of AP31969 in atrial fibrillation
