Learn how an Abbreviated New Drug Application (ANDA) helps generic drugs get FDA approval without clinical trials, ensuring safety and bioequivalence with brand-name drugs.

Novo Nordisk (NVO) announced on Thursday it filed a U.S. marketing application for its next-gen weight loss therapy, CagriSema, which combines its blockbuster obesity drug semaglutide with an amylin ...

RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New ...

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat ...

Novo Nordisk filed an FDA application for weekly CagriSema after trials showed up to 22.7% weight loss versus placebo.

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

The Psychopharmacologic Drugs Advisory Committee of the FDA is set to meet on July 18 to consider a supplemental new drug application for brexpiprazole (Rexulti, Otsuka Pharmaceutical Co., Ltd.), in ...

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 ...

TransThera Sciences Nanjing, Inc. (the TransThera) announced that the new drug application for Tinengotinib tablets has been ...

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 ...

REDWOOD CITY, Calif.--(BUSINESS WIRE)-- Corcept Therapeutics Incorporated (CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, ...