KalVista Pharma has filed its first marketing application to the US FDA, seeking approval for its oral plasma kallikrein inhibitor sebetralstat as an oral treatment for hereditary angioedem
Roche’s move into the digital pathology category has been boosted by FDA approval of a lab instrument and toolkit for use as an aid to clinical diagnosis.
The rivalry between Pfizer and MSD in pneumococcal vaccines has dialled up a notch with the FDA approval of MSD’s new shot Capvaxive, the first to be aimed specifically at adults.
Bristol-Myers Squibb has claimed FDA approval for a new, tumour-agnostic indication for Augtyro, the cancer drug it acquired as part of its $4.1 billion takeover of Turning Point Therapeuti
The Supreme Court has rejected a lawsuit challenging the authority of the FDA to regulate the abortion pill mifepristone, in a move that will ensure it can still be provided by mail-order w
Shares in WuXi Biologics and WuXi AppTec have tracked up after the BIOSECURE Act – which could have profound effects on their businesses in the US – was omitted from legislation due to be f