The European Medicines Agency has recommended authorizing a twice-yearly injectable drug aimed at preventing HIV, which scientists say could help end the virus' transmission.

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

The agency weighed safety data and a new dosing regimen to recommend approval of the treatment for early Alzheimer's disease in certain patients.

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

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 ...

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 ...

Current treatments for Alzheimer’s disease have limited effects. While they can slow cognitive decline or alleviate symptoms, ...

From softwares to implants, here are 10 spine products earning FDA nods since May 15. 1. Accelus’ FlareHawk interbody fusion device was FDA-cleared for use in MRI scanning under certain conditions.

The US FDA has appointed George Francis Tidmarsh, MD, PhD, as director of the Center for Drug Evaluation and Research.

European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...