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Latest From Janssen-Cilag International

EMA Says Yes To BMS’ Sotyktu But Turns Down Ipsen’s Sohonos

The European Medicines Agency has recommended pan-EU marketing approval for four medicines but turned down Ipsen’s treatment for an ultra-rare bone disorder. It has also OK’d new uses of seven already-approved drugs and is reviewing efficacy concerns regarding Novartis’ sickle cell medicine.

Europe Approvals

BioMarin’s Hemophilia Gene Therapy Among Nine Products On Track For EU-Wide Approval

Four orphan drugs and a new COVID-19 vaccine are among the latest products that the European Medicines Agency says should be approved.

Europe Approvals

Janssen’s Multiple Myeloma Gene Therapy On Track For EU-Wide Approval

The European Medicines Agency’s human medicines committee has recommended five new drugs for use in the EU at its latest monthly meeting.

Approvals Drug Review

Janssen’s BCMA-Targeting CAR-T, AstraZeneca’s Evusheld Among EU Verdict Hopefuls

The EMA is poised to say whether or not six new drugs are on track for pan-EU approval, including Janssen’s first cell therapy and an antibody combination to prevent COVID-19 in people with poor immune response.

Approvals Drug Review
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