regulatory

News

Bristol Myers Squibb could be months away from bringing the first 'celmod' to market, as the FDA starts a review of iberdomide for multiple myeloma.

News

The UK has launched a consultation asking whether medical devices with CE marks issued in the EU and sold in GB should be recognised indefinitely.

News

One of the beneficiaries of the FDA's national priority vouchers, Disc Medicine, has had its marketing application turned down by the regulator.

News

PTC Therapeutics has abandoned its latest attempt to secure FDA approval for Duchenne muscular dystrophy treatment Translarna.

News

The FDA has defended its decision to issue a refusal-to-file (RTF) letter for Moderna's new mRNA-based influenza vaccine.

News

Novo Nordisk has been criticised by the FDA for a TV ad for the Wegovy pill, which the agency claims makes "false and misleading" claims.