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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

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Regeneron set for August FDA decision on BCMA bispecific

Regeneron’s bid to join the market for BCMA-targeted bispecific antibodies for multiple myeloma is nearing a conclusion, with the FDA starting a priority review of its lin

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United sues FDA to try to block rival’s drug application

In an unusual move, United Therapeutics has filed a lawsuit against the FDA that claims the regulator is sidestepping established norms in allowing rival Liquidia to file

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

Regeneron set for August FDA decision on BCMA bispecific

United sues FDA to try to block rival’s drug application

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