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AI Doesn’t Get Cited in GMP Inspections; Human Accountability Gets the FDA Warning Letter

Zachary Zubulake reports in PharmTech Explained that industry experts Brian Drapeau and Richard Jaenisch analyzed how AI is reshaping GMP workflows while regulators tighten scrutiny on its use in pharmaceutical manufacturing. The discussion highlights a shift in compliance expectations where
  • News
AI Doesn’t Get Cited in GMP Inspections; Human Accountability Gets the FDA Warning Letter

FDA Approves Lumvoa in Thyroid Eye Disease; A $1.9B Market Monopoly Starts to Crack

The U.S. Food and Drug Administration has approved Viridian Therapeutics’ Lumvoa in the United States for active and chronic thyroid eye disease, expanding treatment options in a previously limited therapeutic area. Announced on June 28, 2026, the decision makes Lumvoa
  • News
FDA Approves Lumvoa in Thyroid Eye Disease; A $1.9B Market Monopoly Starts to Crack

Pharma Temperature Monitoring in 2026: GMP Compliance Risks, Temperature Excursions, and Regulatory Findings

This article explains how temperature monitoring systems support pharmaceutical quality systems through temperature mapping, continuous temperature monitoring, and data logger control. It highlights cold chain monitoring, temperature excursions, and GDP compliance to improve inspection readiness and product safety.
  • Blog, Validation and Qualification
Pharmaceutical cold chain monitoring system showing temperature mapping, data logger tracking, and environmental monitoring used to prevent temperature excursions and ensure storage temperature control under GDP guidelines.

Medicare Expands GLP-1 Coverage; While Frailty Risk Gaps Grow

The U.S. Medicare program will expand coverage of GLP-1 weight-loss medications in July 2026 under the new Bridge initiative, giving seniors with obesity access to semaglutide-based therapies at lower co-pays. The policy aims to improve treatment access for older adults,
  • News
Medicare Expands GLP-1 Coverage; While Frailty Risk Gaps Grow

US FDA Greenlights Rare Metabolic Drug; Ionis Nears First $2B Blockbuster Breakthrough

Ionis Pharmaceuticals has moved closer to its first fully owned blockbuster drug after the US Food and Drug Administration (FDA) expanded approval for Tryngolza (olezarsen) in severe hypertriglyceridemia (sHTG). The decision strengthens the drug’s commercial trajectory, expands its patient reach
  • News
US FDA Greenlights Rare Metabolic Drug; Ionis Nears First $2B Blockbuster Breakthrough

Deviation Reporting in 2026: CAPA Integration, Root Cause Analysis, and GMP Quality Systems

Learn how Deviation Management strengthens GMP inspections through effective investigations, Root Cause Analysis, CAPA effectiveness, and Quality Risk Management. Discover practical strategies to reduce recurring quality issues and build a resilient pharmaceutical quality system.
  • Blog, Quality Management System
Pharmaceutical professionals reviewing GMP Deviation Management, Root Cause Analysis, and CAPA Effectiveness during a GMP quality investigation.

China Outpaces US Trials; FDA TrialBlazer Exposes Pharma Speed Divide

The US Department of Health and Human Services (HHS) has introduced Operation TrialBlazer in Washington, a regulatory blueprint aimed at accelerating early-stage clinical development and narrowing the gap with China’s faster drug discovery timelines. The initiative focuses on simplifying FDA
  • News
China Outpaces US Trials; FDA TrialBlazer Exposes Pharma Speed Divide

Manufacturing Readiness Is Reshaping Pharma M&A; Why GMP Due Diligence Now Drives Deal Decisions

Pharmaceutical dealmaking slowed during the first half of 2026, yet industry experts say transaction quality has become more important than volume. Speaking with Pharmaceutical Technology, KPMG US Life Sciences Sector Leader Kristin Ciriello Pothier explained that manufacturers now place greater
  • News
Manufacturing Readiness Is Reshaping Pharma M&A; Why GMP Due Diligence Now Drives Deal Decisions

Jaypirca Wins CHMP Support; Why Europe Is Moving Toward All-Line CLL Treatment

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Eli Lilly’s Jaypirca (pirtobrutinib) for approval to treat adults with chronic lymphocytic leukemia (CLL) across all lines of therapy, regardless of previous BTK inhibitor treatment. The
  • News
Jaypirca Wins CHMP Support; Why Europe Is Moving Toward All-Line CLL Treatment

Equipment Qualification In Pharma in 2026: GMP Compliance Risks, Validation Failures, and Inspection Findings

Learn how pharmaceutical equipment qualification supports GMP compliance, inspection readiness, and lifecycle control. Explore common qualification failures, IQ OQ PQ qualification practices, requalification triggers, and equipment lifecycle management strategies that help reduce regulatory risk and inspection findings.
  • Blog, Validation and Qualification
Pharmaceutical equipment qualification process showing installation qualification, operational qualification, performance qualification, and equipment lifecycle management in a GMP manufacturing facility