regulatory

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EMA starts twin reviews of AZ, Daiichi’s Dato-DXd

The clock has started ticking in the EU on two marketing applications for AstraZeneca and Daiichi Sankyo’s TROP2-targeting antibody-drug conjugate datopotamab deruxtecan i

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4SC files maintenance CTCL therapy Kinselby in EU

German biotech 4SC has filed its oral HDAC inhibitor Kinselby with the EMA, hoping to provide a much-needed new therapy for patients with the rare cancer cutaneous T-Cell

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MHRA okays first drug under new mutual recognition scheme

A new formulation of Amgen’s cancer treatment Xgeva is the first to be approved in the UK under a new procedure designed to speed up access to new therapies.

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Minerva slumps as FDA finds fault with schizophrenia filing

Shares in Minerva Neurosciences have lost more than half their value after the FDA rejected its marketing application for roluperidone as a treatment for the negative symp

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Bavarian Nordic gets swift EU review of chikungunya shot

Bavarian Nordic will get an accelerated review of its chikungunya vaccine CHIKV VLP at the EMA, as it tries to chase down a lead held by rival Valneva.

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FDA will decide in June on Dupixent for COPD

The FDA has started a priority review of Sanofi and Regeneron’s Dupixent as a treatment for chronic obstructive pulmonary disease (COPD), which could become the first new

EMA starts twin reviews of AZ, Daiichi’s Dato-DXd

4SC files maintenance CTCL therapy Kinselby in EU

MHRA okays first drug under new mutual recognition scheme

Minerva slumps as FDA finds fault with schizophrenia filing

Bavarian Nordic gets swift EU review of chikungunya shot

FDA will decide in June on Dupixent for COPD

Kyverna rises on stiff person syndrome data

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