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 ...
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 ...
The U.S. Food and Drug Administration approved an Investigational New Drug (IND) application using efficacy data solely from ...
NVO files an NDA with the FDA for once-weekly CagriSema, a combo obesity injection showing superior weight loss in obese patients in phase III studies.
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 ...
Clene is planning to submit an application to the FDA in early 2026 requesting the accelerated approval of CNM-Au8 for ALS.
Relacorilant targets glucocorticoid receptor proteins, potentially redefining treatment for platinum-resistant ovarian cancer by inhibiting cancer cell proliferation. Clinical trials show relacorilant ...
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, ...
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