All articles tagged with #eu approval
Merck received positive EU CHMP opinions for its cancer drug KEYTRUDA, including approval for subcutaneous administration and a new indication for earlier-stage head and neck cancer, potentially expanding treatment options in Europe.
The European Medicines Agency has recommended approval for lenacapavir, a twice-yearly injectable drug that could significantly reduce HIV transmission, with potential to help end the epidemic if widely accessible. The drug, already used to treat HIV, has shown nearly 100% effectiveness in preventing transmission in studies and is the longest-lasting prevention option available. While Gilead plans to produce affordable generics for 120 poor countries, concerns remain about limited availability in regions like Latin America, risking missed opportunities to curb global HIV spread.
The European Medicines Agency recommends approval of lenacapavir, a twice-yearly injectable drug that could significantly help prevent HIV transmission, with potential global impact if widely accessible, especially in high-risk and resource-limited settings.
Korean Air has received approval from the European Union for its merger with Asiana Airlines, a move that will create one of the world's largest airline groups. The deal, which was initially announced in November 2020, has faced scrutiny from regulators in various countries, but the EU's green light marks a significant step forward for the merger.
German air taxi firm Lilium has received regulatory approval from the European Union Aviation Safety Agency to design and operate its electric vertical takeoff and landing vehicles. The approval, known as "Design Organization Approval," allows Lilium to manufacture its aircraft while industry rules are being developed. The company aims to launch commercial flights by 2025 and faces competition from Boeing, Airbus, and German start-up Volocopter in the emerging air taxi market.
Shares of iRobot surged by 39% after reports indicated that the European Union is likely to approve Amazon's $1.7 billion acquisition of the company. The deal is expected to receive unconditional antitrust approval from the European Commission by February 14. The acquisition, if approved, would mark Amazon's fourth-largest deal and is still under review by the U.S. Federal Trade Commission.
The European Union's antitrust regulator has given its approval to Microsoft's proposed $68.7-billion acquisition of Activision Blizzard after Microsoft made specific concessions aimed at addressing concerns regarding competition in the cloud gaming market. These concessions ensure that rival companies would continue to have access to games developed by Activision, including the immensely popular "Call of Duty" franchise. The approval is conditional on full compliance with the commitments offered by Microsoft.