regulatory

News

Novo Nordisk has been sent a warning letter from the FDA for violations of postmarketing adverse drug experience (PADE) regulations.

News

The FDA has issued additional guidance that aims to make it easier for drugmakers to bring biosimilars of patent-expired biologic drugs to market.

News

For the second time in less than a year, Vinay Prasad has departed from the FDA, after a string of controversial regulatory decisions.

News

Shares in PepGen fell sharply after the FDA placed a partial clinical hold on its lead drug for rare neuromuscular disease DM1.

News

The FDA has started reviewing Hansa's imlifidase for highly sensitised adults needing a kidney transplant, but not in the requested rapid timeframe.

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