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The approval provides another treatment option for pediatric patients, who were previously given non-selective immunosuppressants and corticosteroids, the company said. Read More
Sandoz’s biosimilar of Biogen’s blockbuster multiple sclerosis drug Tysabri (natalizumab) has gained new regulatory footholds with both the FDA and the European Medicines Agency (EMA). Read More
Gilead is seeking approval of lenacapavir for treatment of HIV-1 infection in heavily treatment-experienced individuals with multi-drug resistant HIV-1 infection. Read More
The European Medicines Agency (EMA)’s human medicines committee endorsed nine new drugs during its June meeting, including Valneva’s adjuvanted COVID-19 vaccine for use in people age 18 to 50 years. Read More