The FDA has drastically cut the time for biosimilar drug approval, aiming to halve the market entry period. This move by the Trump administration targets high biologic drug prices by fostering competition. The reform allows for analytical data to replace extensive human trials, potentially lowering»»»

The already fraught oversight of rare-disease treatments is becoming politicised TO APPRECIATE the dilemmas the Food and Drug Administration (FDA) faces when it reviews new drugs targeting rare diseases, consider the recent rollercoaster ride of Sarepta Therapeutics, a biotech firm. In 2023 the FDA»»»