Comprehensive VAX-31 Adult Phase 3 Clinical Program, Finalized in Consultation and Alignment with FDA, Advances with Three Phase 3 Studies Underway to Support Planned BLA Submission ...

WASHINGTON - The Food and Drug Administration on Monday introduced a regulatory pathway aimed at accelerating the development ...

When Mya Brewer came away from a conference in Topeka recently, she noted that “it was a great opportunity to speak up and speak out.” ...

Louisiana Attorney General Liz Murrill will argue in federal court in Lafayette Tuesday for an injunction to stop the FDA's authorization of mail-order abortion drugs.

UB will will host its annual Rare Disease Day event from 1-5 p.m. on Friday, Feb. 27, in the Jacobs School of Medicine and Biomedical Sciences, 955 Main St., Buffalo.

Late-breaking presentation at MDA to feature Phase 3 HOPE-3 results supporting Deramiocel in Duchenne muscular ...

The FDA released a much-anticipated draft guidance on how makers of rare disease genetic medicines can leverage a platform ...

The Food and Drug Administration will consider whether to approve Moderna’s new flu vaccine after all, resolving a dispute that had ...

The Battle of the Bulge Association (BOBA) and World War II American Experience will host their third annual conference on Saturday, Feb. 28, starting at 9 am., at the World ...

According to an FDA press release, the draft guidance "focuses on therapies that target a specific genetic, cellular, or molecular abnormality and are designed to correct or modify the underlying ...

The FDA supports mRNA vaccines, but taxpayers should not foot the bill, Makary ‌said, referring to several Health Department ...

The FDA warns that a substance "13 times more potent than morphine" threatens to be "the next wave of the opioid epidemic." ...