FDA
FDA Updates Opioid Labeling Requirements to Reflect Long-Term Risks
The FDA announced major changes to its opioid pain medication labeling regulations that better emphasize and ...
AUGUST 27, 2025
FDA Vaccine Advisory Committee Meeting Canceled
With no explanation, the FDA canceled the meeting of VRBPAC, scheduled to discuss the makeup of the 2025-2026 ...
MARCH 7, 2025
FDA Highlights Importance of DPD Deficiency Discussions With Patients Before Capecitabine or 5-FU Treatment
The FDA has provided a communication to increase awareness of recent updates to the product labeling of ...
MARCH 6, 2025
Breathing New Life Into the NSCLC Pipeline
The next two years may well see an explosion of FDA approvals for non-small cell lung cancer, with some of the ...
NOVEMBER 20, 2024
FDA Approves Next-Gen mt-sDNA test, Cologuard Plus
The FDA has approved the next-generation of the multitarget stool DNA test Cologuard (Exact Sciences).
OCTOBER 28, 2024
FDA Issues Draft Guidance on Conducting Multiregional Clinical Trials in Oncology
The FDA has issued a draft guidance for industry that, when finalized, will provide sponsors with recommendations ...
SEPTEMBER 17, 2024
Sussing Out a 2nd Cancer Signal for CAR-T Therapy
The FDA recently required a classwide boxed warning on all commercial CAR T-cell therapies after an investigation ...
JULY 1, 2024
Truseltiq Has FDA Approval Withdrawn for Cholangiocarcinoma
The FDA has announced the final withdrawal of its approval of infigratinib (Truseltiq, QED Therapeutics) for adults ...
JUNE 11, 2024
FDA Approves First mt-sRNA Test for CRC Screening in Average-Risk Adults
The FDA has approved the first multitarget stool RNA test for colorectal cancer screening in typical average-risk ...
MAY 27, 2024
FDA Approves New Indication for Abecma in Multiple Myeloma
The FDA approved idecabtagene vicleucel (ide-cel) (Abecma, Bristol Myers Squibb/2seventy bio) for the treatment of ...
APRIL 10, 2024
FDA Requires Boxed Warning of Secondary Malignancies for CAR-T Therapies
The FDA has called for a classwide boxed warning on all commercial CAR T-cell therapies after an investigation into ...
FEBRUARY 15, 2024
FDA Approves New Safety Labeling Changes for Opioid Medications
Recently, the FDA announced final approval and implementation of updated warning labels for all opioid ...
FEBRUARY 13, 2024
