The U.S. Food and Drug Administration Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend use of Takeda Pharmaceutical Company Limited’s maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease withgenotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients.
The European medicines watchdog recommended approving AstraZeneca’s treatments for a form of heart failure and a lung disorder, the British drugmaker said.
Swiss drugmaker Novartis grabbed a key European panel’s recommendation for Leqvio, clearing the way for the prospective cholesterol drug’s approval in the next couple of months.
The European Medicines Agency (EMA) recommended approval for Lynparza in patients with a form of prostate cancer and as a first-line maintenance treatment for a form of advanced ovarian cancer, the British drugmaker AstraZeneca said.
A panel of the European Medicines Agency recommended approving GlaxoSmithKline’s experimental treatment for a common form of blood cancer, days after a similar nod from a U.S. Food and Drug Administration panel.
Swiss drugmaker Novartis won a key European recommendation for the company’s gene therapy Zolgensma against spinal muscular atrophy (SMA), clearing a hurdle for $2.1 million per patient treatment for approval in Europe within months.
Takeda Pharmaceutical Co.’s lung cancer drug Alunbrig received the recommendation of a European Union panel, more than a year after winning U.S. regulatory approval.
A European Medicines Agency panel recommended approval of Spark Therapeutics’ gene therapy Luxturna for blindness, a move that also boosts Swiss drugmaker Novartis that bought the rights to one of the world’s costliest treatments outside the United States.
Puma Biotechnology Inc. won a key recommendation from a European Medicines Agency panel on the company’s lead breast cancer drug, five months after the regulator recommended against approving it.
Pfizer Inc. announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted positive opinions recommending that two Pfizer hematology medicines be granted marketing authorizations in the European Union.