If approved, it would be the first major new drug treatment for Parkinson’s in half a century. Richard Mailman, a University ...

The FDA has accepted Pharming Group’s supplemental new drug application for leniolisib in treating activated phosphoinositide ...

In the PIV Notice, WhiteOak alleges that the claims of 19 EXPAREL patents listed in the FDA’s Orange Book (U.S. Patent Nos.11 ...

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to DPTX3186, an investigational therapy being ...

The FDA’s effort to expedite reviews for drugs in line with the Trump administration’s priorities was greeted warmly by a ...

Once-daily Precision Timed Release™ (PTR™) stimulant designed to deliver rapid onset of effect and entire active-day duration NDA accepted under the FDA’s 505(b)(2) regulatory pathway KANSAS CITY, Kan ...

Relacorilant targets glucocorticoid receptor proteins, potentially redefining treatment for platinum-resistant ovarian cancer by inhibiting cancer cell proliferation. Clinical trials show relacorilant ...

China Medical System Holdings ( (HK:0867) ) just unveiled an announcement. China Medical System Holdings has announced that its subsidiary, Dermavon Holdings, has had its new drug application for ...

FDA assigns a Prescription Drug User Fee Act (PDUFA) date of July 11, 2026 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of ...

With a government shutdown now in effect, the U.S. FDA—already shaken up by head count reductions earlier this year—has sought to keep many of its functions running for the foreseeable future. But the ...

During his first term in office, President Trump’s FDA approved abortion pill manufacturer GenBioPro’s abbreviated new drug ...