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FDA Approves Tregzi; Manufacturing Data Became the Real Approval Story

Orca Bio has received FDA approval for Tregzi, the first engineered regulatory T-cell therapy designed to reduce chronic GVHD following allogeneic stem cell transplantation in adults with blood cancers. While the approval marks a major clinical achievement, it also highlights
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FDA Approves Tregzi; Manufacturing Data Became the Real Approval Story

Congress Scrutinizes China Trial Sites; Insider Probe Reveals Pharma Risk Exposure

A U.S. congressional committee has launched an investigation into clinical trial activities conducted by Pfizer and Bristol Myers Squibb in China. Representative John Moolenaar raised concerns about trial sites linked to military-run facilities and regions such as Xinjiang. The inquiry
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Congress Scrutinizes China Trial Sites; Insider Probe Reveals Pharma Risk Exposure

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

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

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

Mayo Clinic Reveals Hidden Limits; AI Can’t Fully Automate Revenue Cycles

Mayo Clinic is applying artificial intelligence across its revenue cycle operations to streamline repetitive administrative workflows, while maintaining human oversight in clinical and billing decisions. Revenue cycle chair Todd Manion shared these insights during an interview at HFMA’s annual conference
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Mayo Clinic Reveals Hidden Limits; AI Can’t Fully Automate Revenue Cycles