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The label update reinforces the safety and effectiveness data of Leqvio generated by the VictORION clinical trial programme, claimed the company. Leqvio was initially approved by the FDA

The study will be carried out at several US-based clinical cancer research centers including the MD Anderson Cancer Center in Houston, Texas. 280Bio intends to enroll patients for

The full MA is based on positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use, and replaces the conditional Marketing Authorization. As

The approval was based on an import approval application filed by Toray and its partner 3SBio in November 2021 for alleviating pruritus in people with chronic liver disease.

The authorisation is based on the data from the global, open label FOENIX-CCA2 trial. It enrolled a total of 103 adult patients from the Netherlands, UK, Spain, Italy,

A single-time, recombinant adeno-associated virus (rAAV)-mediated gene therapy for ocular disease, SKG0106 is administered intravitreally. The global Phase I trial will begin shortly. SKG0106 consists of a new AAV

The treatment is indicated for usage in areas that are not covered by the reference medicine Humira’s regulatory exclusivity. The indications include inflammatory ailments namely juvenile idiopathic arthritis,

Bellus focuses on improving the lives of individuals suffering from persistent cough. In April this year, GSK reached an agreement for the acquisition of Bellus Health. The takeover comprises the

The letter is based on a continuing assessment of inspection data at a third-party filler. No issues linked to aflibercept’s clinical safety or efficacy, design of the clinical