While interested in CAR-T therapies’ potential to achieve durable, drug-free remission in serious autoimmune conditions, the ...

The FDA approved Scancell's phase 3 trial of iSCIB1+ for advanced melanoma, focusing on progression-free survival as a ...

The findings show diligence from the FDA and a need for clinicians to discuss risks, benefits, and unknowns with patients before using drugs with accelerated approval.

DOJ accuses Louisiana AG, alleged victim of abortion coercion of trying to "short circuit" FDA's review of mifepristone's ...

FDA drug alerts in endocrinology, including drug approvals, drug warnings, FDA medical device recalls, and FDA drug label ...

Aquestive Therapeutics announced it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Anaphylm (dibutepinephrine) Sublingual Film, a noninvasive ...

FDA commissioner Marty Makary said it would be “magical” for consumers to see prescription drugs on pharmacy shelves instead ...

The FDAAA did not significantly alter the overall time to first postmarket safety action for novel therapeutics. Earlier safety actions were observed within the first five years post-approval, ...

In January, the FDA released its 2026 Priority Deliverables for its Human Foods Program (HFP), which oversees all food safety ...

Jan 27 (Reuters) - Intellia Therapeutics said on Tuesday that the U.S. drug regulator has lifted a clinical hold on one of ...

By Kamal Choudhury Jan 30 (Reuters) - Shares of Corcept Therapeutics fell 16% on Friday after a corrected "complete response ...

The FDA accepted an application for ivonescimab with chemotherapy for patients with lung cancer driven by EGFR changes after ...