Page 48 - Human Use News Today

GHTC submitted the following comments in response to a World Health Organization (WHO) public consultation seeking input on its draft guidance for best practices for clinical trials.

The Committee for Medicinal Products for Human Use has recommended the approval of quizartinib in the European Union for use in combination with standard cytarabine and anthracycline induction and cytarabine consolidation chemotherapy, followed by maintenance quizartinib, for adult patients with newly diagnosed acute myeloid leukemia.

EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna’s Updated Covid-19 Vaccine in The European Union The positive opinion follows the...

Argenx SE (ARGX), a Dutch immunology company, Friday announced that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has recommended European Commission approval for Subcutaneous Efgartigimod to treat Generalized Myasthenia Gravis or gMG.

-If approved, more than 1,200 children would be newly eligible for a medicine that could treat the underlying cause of their disease- ...

By Colin Kellaher Shares of PTC Therapeutics fell 21% in premarket trading Friday after the biopharmaceutical company said European approval of its key...

By Dean Seal European regulators have adopted a positive opinion of Vertex Pharmaceuticals' drug Kaftrio, a treatment for children with cystic fibrosis. The...

By Colin Kellaher Merck & Co. on Friday said the European Medicines Agencys Committee for Medicinal Products for Human Use recommended expanded approval of its blockbuster cancer drug...

Positive opinion based on Phase 3 ADAPT-SC study demonstrating noninferior total IgG reduction at day 29 with subcutaneously (SC) administered...

(RTTNews) - Biopharmaceutical company Merck & Co., Inc. (MRK), known as MSD outside of the U.S. and Canada, announced Friday that the European Med...