October 03, 2025

FDA Sets Science Agenda for Generics: Priorities for 2026

The FDA has unveiled its top science and research priorities for FY 2026 under the GDUFA program, including nitrosamine risk, complex drug development, bioequivalence innovations, and the use of AI and modeling to modernize generics regulation.

The Medicine Maker

October 03, 2025

Court Upholds State's "Doctor" Title Ban

Federal judge rules nurse practitioners with doctorates cannot use “doctor/Dr.” in advertising or health care settings likely to make patients think they’re physicians. 

Conexiant

October 03, 2025

Fruit Intake: Does It Alter PM2.5 Effect?

UK Biobank analysis examines diet quality and fruit intake in relation to PM2.5 lung effects.

Conexiant

October 03, 2025

From Agent Orange to PCBs: Lessons for Care

Air Force reviews cancer risk in missile crews; early analyses show no excess mortality, but exposures to PCBs and benzene prompt vigilance and targeted histories.

KFF Health News

October 02, 2025

FDA Removes Vandetanib REMS Program

On September 25, the U.S. Food and Drug Administration (FDA) removed the Risk Evaluation and Mitigation Strategies (REMS) program for vandetanib, according to an announcement from the agency. 

The ASCO Post

October 01, 2025

How Safe Are FDA-Cleared AI Tools?

“These findings indicate that standardized efficacy, safety, and risk assessment reporting remains inadequate for FDA-cleared AI/ML devices, underscoring the need for dedicated regulatory pathways and robust postmarket surveillance to ensure patient safety."

Conexiant

October 01, 2025

Remibrutinib Gains FDA Nod for Urticaria

First oral BTK inhibitor approved for antihistamine-resistant chronic spontaneous urticaria, targeting mast cell–driven immune dysregulation

Conexiant

September 29, 2025

FDA Expands Options for Pediatric Psoriasis, PsA

The FDA has approved the first IL-23 inhibitor for pediatric patients with plaque psoriasis and psoriatic arthritis.

Conexiant

September 29, 2025

The 7-Day Risk ACIP Didn't Address

Delaying newborn hepatitis B shots may leave infants exposed to everyday transmission risks.

KFF Health News