regulatory

News

New draft guidance from the FDA is urging pharma companies to accelerate efforts to transition from animal testing to non-animal alternatives.

News

The aligned regulatory pathway for UK drugs regulator MHRA and reimbursement authority NICE gets underway on 1st April.

News

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

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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.