On August 15, 2025, the U.S. Court of Appeals for the D.C. Circuit limited FDA's ability to deny a hearing on the approvability of a new drug application (NDA) based on a lack of “substantial evidence ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

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 ...

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 ...

Ziftomenib targets relapsed/refractory AML with NPM1 mutations, a condition with high relapse rates and poor survival outcomes. The drug has received breakthrough therapy, fast track, and orphan drug ...

The FDA is launching a National Priority Voucher program to accelerate reviews of certain new drug applications. The agency will distribute a limited number of vouchers in the program’s first year to ...

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 ...

The development of new, safe, and effective drugs for diseases such as cancer, infectious diseases, and autoimmune disorders ...

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. Subscribe to our ...

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) submissions for ...

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 ...