FDA grants approval for Veklury use in Covid-19 patients
This therapy is intended for use in patients with severe renal impairment including those on dialysis. The latest announcement comes after the decision from European Commission to extend
This therapy is intended for use in patients with severe renal impairment including those on dialysis. The latest announcement comes after the decision from European Commission to extend
The FDA-approved oral sodium-glucose cotransporter 2 (SGLT2) inhibitor Brenzavvy is available as 20 mg tablet and is recommended once daily in the morning with or without food. It
In April this year, Astellas Pharma’s subsidiary agreed to buy 100% of the outstanding shares of Iveric Bio for $40 per share in cash for a total equity value of about
The provisional approval comes with a duration of two years. It is based on the data from Phase II studies that enrolled highly sensitised patients who received imlifidase
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