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 ...

Over the first weeks of July 2025, the U.S. Food and Drug Administration (FDA) has issued several announcements heralding new policies and proposed regulatory changes that could dramatically impact ...

Please provide your email address to receive an email when new articles are posted on . The single inhaler includes an inhaled corticosteroid, a long-acting beta-agonist and an anticholinergic. The ...

The Prescription Drug User Fee Act target guidelines for NDA resubmissions include acknowledgment of acceptance for review ...

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 ...

The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response Letters (CRLs) on openFDA, one of several steps taken under ...

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 ...