A new technology that harnesses AI to analyze mammograms and improve the accuracy of predicting a woman's personalized ...

The Food and Drug Administration’s polarizing vaccine chief is leaving the agency after a brief tenure that drew the ire of ...

Additional clinical sites in the EU will assess HT-001 for the treatment of skin toxicities associated with EGFRi.

If it does rescind the finding, regulations on vehicle and power-plant emissions, which Mr Zeldin claims cost “$1trn or more ...

Dr. Vinay Prasad, the controversial critic of the US Food and Drug Administration who took a top role at the regulatory ...

Apellis Pharma (APLS) stock in focus as the FDA expands the label for its injectable therapy Empaveli to treat rare kidney ...

COPENHAGEN (Reuters) -Investors knocked $70 billion off Novo Nordisk's market value on Tuesday after the maker of weight-loss ...

The FDA granted 510(k) clearance to two devices, HyHub and HyHub Duo, that act as docking stations for dual vial units to ...

Improving how the FDA disseminates already-public information about approved drugs may be unsexy, but it would be a big step ...

Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping its gene therapy. The company's stock has been under pressure for ...

MAGiC Sweep is claimed to be the first robotically navigated electrophysiology mapping catheter approved by the FDA.

An epidemic that's been sustained for 44 years might finally be quelled, with the milestone approval of the first HIV drug ...