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 ...

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

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 ...

KANSAS CITY, Kan., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform ...

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

NEEDHAM, Mass., Aug. 18, 2025 /PRNewswire/ -- Stealth BioTherapeutics, a clinical-stage biotechnology company focused on the discovery, development and commercialization of novel therapies for ...

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 ...

CHENGDU, China, Sept. 22, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that a new drug application (NDA) for the Company's small molecule rearranged ...

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

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 ...