The topical ocular drug is an investigational new drug candidate that requires more well-controlled studies to establish ...

Aldeyra (ALDX) announced receipt of a complete response letter from the FDA for the resubmission of the new drug application of reproxalap, an ...

The FDA has long believed it has the power to regulate lab-developed tests, but it only put out the rules under former ...

In every corner of the FDA, and at sister health agencies like the CDC, support staff, specialists, and scientists were hit with DOGE pink slips.

It is unclear what will happen to hundreds of pending requests for public information as the health agencies slash staff.

Dr. Peter Marks made clear that a central impetus behind his resignation was Kennedy’s criminal response to the deepening ...

Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...

According to the FDA’s public database, since the start of this year, the agency has issued only two de novo medical device ...

DBV Technologies (DBVT) announced that in a written responses only to the company’s Type D IND meeting request, the FDA agreed with the ...

has received U.S. Food and Drug Administration (FDA) approval for the treatment of adults with C3 glomerulopathy (C3G), to reduce proteinuria, making it the first and only treatment approved for ...

Planned single, pivotal Phase 2/3 clinical trial, if positive, acceptable for Biological License Application (BLA) submission for Alzheimer’s disease Alignment with FDA on proposed trial ... to ...

(WBOY) — Following last month’s mass layoffs, former employees at Leer South Mine in Barbour County were invited to Rapid Response meetings Tuesday hosted by ... such as career training and resume ...