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.

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

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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 ...

Achieve Life Sciences, Inc. has submitted a New Drug Application (NDA) to the U.S. FDA for cytisinicline, which, if approved, would be the first new pharmacotherapy for nicotine dependence in 20 years ...

The U.S. Food and Drug Administration is reviewing a new Parkinson’s disease drug called tavapadon that could give people with the disease more control over their movements. If approved, it would be ...

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 ...