For selected applicants, the agency plans to cut review times down to one to two months and provide "tumor board-style" ...

Clinical trials have shown that six-monthly injections of lenacapavir are almost 100 percent protective against becoming ...

The Food and Drug Administration approved the drug for adult patients with bullous pemphigoid, which mainly affects the ...

Researchers from Purdue University and the U.S. Centers for Disease Control and Prevention have recently developed a novel influenza vaccine candidate that uses a bovine adenoviral (BAd) vector to ...

On Wednesday, the Food and Drug Administration approved a highly effective, injectable drug to help prevent the transmission ...

Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...

The FDA approved Gilead's HIV prevention drug lenacapavir, a twice-a-year injectable medication that clinical trials show ...

The Food and Drug Administration has approved a new drug that could prevent HIV infections with just two shots every year and ...

Clinical trials showed 99.9% of participants who received the drug, called Yeztugo​ from company Gilead Sciences, remained ...

FDA Commissioner Dr Marty Makary tried to allay industry concerns about recent cuts and outlined his agenda for the future.

Experts have urged the Philippine government to expedite the approval of a new-generation of dengue vaccine, amid the rising ...

FDA drug alerts in infectious diseases, including new drug approvals, safety warnings, recalls, and changes in indications.