The US Food and Drug Administration appears poised to continue with a plan to ban prescription fluoride supplements at a time ...

The approval was based on data from the randomized, double-blind, placebo-controlled phase 3b AVA-PED-301 trial.

Doptelet and new oral sprinkle granules is approved for children one year and older with chronic immune thrombocytopenia, ...

LONDON — The European Medicines Agency has recommended authorizing a twice-yearly injectable drug aimed at preventing HIV, ...

Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.

Verastem Oncology's VS-7375 receives FDA fast track designation, offering hope for targeted treatment in KRAS G12D-mutated ...

Four months after giving Eli Lilly’s Alzheimer’s disease treatment  a thumbs down, Europe’s Committee for Medicinal Products ...

A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...

Mike Pence's think tank is asking the Food and Drug Administration to turn over documents related to the dangers of the ...

As life-extending technologies and aging interventions proliferate, questions surround who will be granted access to a longer ...

The European Medicines Agency has recommended authorizing a twice-yearly injectable drug aimed at preventing HIV, which ...

The European Medicines Agency has recommended authorizing a twice-yearly injectable drug to prevent HIV. Scientists say this ...