regulatory

News

The FDA has steadied the ship at CDER by naming veteran regulator Richard Pazdur as director, although he was reportedly reluctant to take the job.

News

The battle for obesity drug developer Metsera rumbles on, with Pfizer reported to have now matched Novo Nordisk's $10 billion offer.

News

Biohaven's troriluzole candidate for spinocerebellar ataxia (SCA) has been turned down by the FDA, in another sign of a tougher stance by the agency.

News

uniQure has revealed that the FDA has said it is not prepared to review its Huntington's gene therapy in what seems to be a change in policy.

R&D

Automation holds the potential to enhance scientific rigour and operational efficiency while solving long-standing regulatory conundrums.

News

The FDA has proposed a radical change to the regulatory requirements for bringing biosimilar medicines to market as a way to cut US drug prices.