US FDA rejects AstraZeneca's easy-to-use version of lupus drug Saphnelo

Feb 3 (Reuters) - AstraZeneca said on Tuesday the U.S. health regulator has rejected its application for a self-injectable ...

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

A plan to slash drug review times at the Food and Drug Administration is sparking deep concerns among agency staffers and outside experts, with some saying the poorly defined effort is taking key ...
JD Supra

FDA PreCheck Pilot Program Launches, Clearing a Smooth Path to Approval

On February 1, 2026, the Food and Drug Administration (FDA) officially started accepting requests to participate in the FDA PreCheck pilot ...
Fierce Healthcare

The Trump administration is creating clinical AI agents with a 3-year FDA approval timeline

The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals to develop two agentic artificial intelligence assistants for clinical care. It hopes to set a novel regulatory ...
Cure Today

Every FDA Oncology Approval From November 2025

Stoboclo and Osenvelt were approved as interchangeable biosimilars for bone loss conditions, potentially reducing costs and increasing access. Darzalex Faspro was approved for high-risk smoldering ...
Targeted Oncology

FDA Issues Draft Guidance on MRD and CR End Points in Multiple Myeloma

The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...
FiercePharma

Incyte to seek FDA approval for 7-drug Monjuvi regimen in 1st-line diffuse large B-cell lymphoma

A positive top-line readout from a phase 3 trial has emboldened Incyte to seek the FDA’s blessing for the company’s Monjuvi as a first-line treatment for diffuse large B-cell lymphoma (DLBCL). The ...