The U.S. Food and Drug Administration on June 4 approved Danish drugmaker Novo Nordisk’s once-weekly semaglutide drug as a treatment for obesity, a condition that affects nearly 70% of American adults.
The U.S. health regulator authorized a lower dose of Regeneron Pharmaceuticals’ Covid-19 antibody cocktail that can be given by injection, a move that could ease logistical challenges stemming from administering a higher dose intravenously.
The U.S. Food and Drug Administration approved a prefilled syringe for self-injection of the allergic diseases treatment Xolair developed by Novartis and Genentech, a Roche company.
The U.S. Food and Drug Administration approved Biogen Inc.’s new intramuscular injection route of administration for Plegridy (peginterferon beta-1a) for the treatment of relapsing forms of multiple sclerosis.
Ridgeback Biotherapeutics LP’s Ebanga is the first FDA-approved, single-injection Ebola treatment which is available in a lyophilized form.
GlaxoSmithKline Plc said an injection of the company’s cabotegravir drug given every two months, in combination with Johnson & Johnson’s rilpivirine, was recommended for approval to treat HIV infections by a panel of the European health regulator.
The U.S. Food and Drug Administration approved Novartis’ Kesimpta (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis in adults.
Britain’s GSK said an injection of the company’s cabotegravir drug given every two months was found to be 65 percent more effective in preventing HIV infections than Gilead’s Truvada daily oral pills.
GlaxoSmithKline’s HIV business ViiV is within weeks of resubmitting the request for approval of the long-acting injection Cabenuva to the U.S. drug regulator.
Nexus Pharmaceuticals received U.S. Food and Drug Administration approval for the company’s New Drug Application for Emerphed, the first premixed ephedrine in a ready-to-use 50 mg/10 mL vial.