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 ...

Patent reforms could address a problem that’s been driving rising prescription drug costs and create a more competitive ...

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 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 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 ...

Taletrectinib's NDA is based on phase 2 TRUST-I and TRUST-II trials, showing significant efficacy in ROS1-positive NSCLC. The trials reported tumor shrinkage in 89% of TKI-naive and 56% of ...

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 ...

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 ...

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 ...

CHENGDU, China, Sept. 22, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that a new drug application (NDA) for the Company's small molecule rearranged ...

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 ...