The United States has initiated Section 232 national security investigations into imports of medical equipment, personal protective equipment (PPE), and medical devices, sending shockwaves through
The pharmaceutical industry’s marketing playbook is about to get a major rewrite. The FDA has announced an aggressive campaign against misleading drug advertisements, signaling the
HHS directive linked to BARDA funding scale-back reflects shifting pandemic priorities and mRNA policy changes Vaxart has laid off 10% of its staff after the
Brinsupri becomes groundbreaking DPP1 inhibitor therapy addressing decades of unmet medical need in rare respiratory disease Insmed Corporation achieved a historic regulatory milestone with FDA
President Trump to discuss policies boosting domestic drug production and innovation investment The White House announced plans for President Trump to meet with pharmaceutical industry
Voluntary early-review initiative shifts to preventive manufacturing quality oversight The FDA launched a new “Pre-Check” voluntary program allowing pharmaceutical manufacturers to undergo proactive quality systems
Vepdegestrant PROTAC estrogen receptor degrader targets ER+ breast cancer with novel mechanism The FDA accepted Arvinas and Pfizer’s New Drug Application for vepdegestrant (ARV-471), granting
Thermo Fisher’s companion diagnostic enables precision treatment with zongertinib for rare NSCLC subset The FDA approved Thermo Fisher Scientific’s Oncomine Dx Target Test as a
PharmaTher’s KETARx becomes first FDA-approved ketamine formulation for on-label surgical use In a historic regulatory milestone, the FDA approved PharmaTher’s KETARx on August 8, 2025,
Healthcare policy analysts are projecting potentially significant premium increases of up to 20% for Affordable Care Act (ACA) marketplace plans in 2026, driven by a
