The U.S. Food and Drug Administration approved Pfizer Inc.’s biosimilar to Roche Holding AG’s blockbuster cancer treatment Avastin.
GlaxoSmithKline’s two-drug treatment for HIV infections won marketing approval from a European Medicines Agency panel. The British drugmaker received U.S. FDA approval in April 2019.
An advisory committee of the EMA recommended conditionally approving a drug from Akcea Therapeutics and Ionis Pharmaceuticals that aims to treat a rare genetic disease.
An EMA panel recommended approving a potential blockbuster drug from Shire Plc to treat a rare hereditary disease.
The European Medicines Agency’s CHMP adopted a positive opinion for the marketing authorization of Sanofi’s dengue vaccine.
The EMA’s risk assessment committee recommended restrictions on the use of the broad-spectrum antibiotics.
Bayer AG’s long-acting treatment for hemophilia A won a recommendation from a European Medicines Agency (EMA) panel for the treatment of the rare genetic disorder in which blood does not clot easily.
A European Medicines Agency panel recommended the approval of U.S. pharmaceutical group Eli Lilly’s migraine treatment, bringing the drug one step closer to being sold in the European Union.
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.