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 ...
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.
The filing comes as Novo fights tooth-and-nail with rival Lilly to regain its footing at the top of the weight loss market.
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.
TransThera Sciences Nanjing, Inc. (the TransThera) announced that the new drug application for Tinengotinib tablets has been ...
Stockholm, Sweden, December 19, 2025. Egetis Therapeutics AB (publ) ("Egetis" or the "Company") (NASDAQ Stockholm: EGTX), today announced that the Company has initiated a rolling New Drug Application ...
The U.S. Food and Drug Administration approved an Investigational New Drug (IND) application using efficacy data solely from ...
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 ...
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