Loyal’s application for drug approval is another step closer to potential approval through the FDA Center for Veterinary ...

The FDA has accepted an investigational new drug application for an investigational and proprietary combination therapy to ...

Takeda and Protagonist Therapeutics have submitted a new drug application to the FDA for rusfertide for adults with ...

46 new molecular entities cleared the agency’s hurdles last year, 4 fewer than in 2024 ...

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

Shares of GH Research rose on plans to provide an update on the status of its investigational new drug application for GH001, a therapy for treatment-resistant depression. The stock climbed 19% to $15 ...

Aquestive Therapeutics (AQST) stock plunges as FDA flags deficiencies in the company's new drug application for its allergy ...

AbbVie is seeking a new way to fight chronic lymphocytic leukemia, or CLL, by combining its oncology drug Venclexta with another cancer-fighting drug. The North Chicago-based drugmaker has filed a ...

After an FDA rejection in May, Stealth BioTherapeutics has resubmitted a new drug application for its investigational treatment designed to treat an ultra-rare genetic disease. This is the biotech’s ...

LOR is the first drug candidate with disease-modifying potential for osteoarthritis submitted for approval, demonstrating ...

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 ...

US FDA accepts Axsome Therapeutics’ supplemental New Drug Application for AXS-05 to treat Alzheimer’s disease agitation: New York Saturday, January 3, 2026, 12:00 Hrs [IST] Ax ...