CURE

FDA Accepts Gedatolisib Application for Some With Breast Cancer

The U.S. Food and Drug Administration (FDA) has accepted a new drug application for gedatolisib in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), PIK3CA ...

Legal questions swirl around FDA’s new expedited drug program, including who should sign off

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...

Takeaways from the AP’s report on turmoil surrounding the FDA’s new fast-track drug program

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...
Yahoo Finance

NEW DRUG APPLICATION FOR TINENGOTINIB TABLETS ACCEPTED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION

NANJING, China and GAITHERSBURG, Md., Dec. 18, 2025 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (the "TransThera") announced that the new drug application for Tinengotinib tablets has been ...
Healio

FDA clears new drug application for CAR T-cell therapy in SLE with lupus nephritis

Please provide your email address to receive an email when new articles are posted on . ATA3219 is an allogeneic CAR T-cell therapy being investigated in the treatment of SLE with lupus nephritis. The ...

Exclusive-US FDA delays two drug reviews in new voucher program after safety, efficacy concerns

By Patrick Wingrove Jan 15 (Reuters) - The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the ...