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.
Investing.com -- Sanofi SA (EPA:SASY) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application of tolebrutinib, which was ...
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 ...
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 ...
The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program designed to shorten review time for a drug application.
Relacorilant targets glucocorticoid receptor proteins, potentially redefining treatment for platinum-resistant ovarian cancer by inhibiting cancer cell proliferation. Clinical trials show relacorilant ...
Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat ...
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 ...
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, ...
TransThera Sciences Nanjing, Inc. (the TransThera) announced that the new drug application for Tinengotinib tablets has been ...
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