Policy - BioReview

Policy

The Lobbyist Who Ran Out of Road: What Steve Ubl's Departure Reveals About Pharma's Washington Problem

Steve Ubl's announcement that he will step down as president and CEO of PhRMA signals that the political architecture the pharmaceutical industry built over the past decade is under unprecedented stress.

Policy

The Tariff Ultimatum: What Trump's 100% Drug Levy Means for the Pharmaceutical Industry

Trump's executive order imposing 100% tariffs on imported branded pharmaceuticals marks a structural turning point for the industry. Here is what the order actually says, who it protects, and what it risks.

Biotechnology

Crossing the Barrier: What Denali's Hunter Syndrome Approval Reveals About the FDA's Rare Disease Reckoning

The FDA's approval of Denali's Avlayah marks a breakthrough in blood-brain barrier delivery and signals the agency's continued commitment to rare disease innovation amid recent regulatory turbulence.

Pharmaceuticals

The $400 Billion Orphan: How Rare Disease Drugs Became Pharma's Most Resilient Franchise

Evaluate's 2026 Orphan Drug Report projects rare disease drug sales will exceed $400 billion by 2032. Behind the headline number lies a more complicated story about FDA volatility, IRA policy shifts, and the structural forces reshaping who wins in rare disease medicine.

Policy

When Geopolitics Hits the Hospital: The Stryker Cyberattack and the New Vulnerability of Medtech

Shortly after midnight on March 11, 2026, thousands of Stryker employees discovered their devices had been wiped by Handala, a pro-Iran hacktivist group. The attack exposes a critical vulnerability: medtech companies can no longer assume neutrality in geopolitical conflicts.

Policy

After Prasad: What the FDA's Revolving Door Means for Biotech's Regulatory Future

Vinay Prasad's departure from the FDA's Center for Biologics Evaluation and Research marks another chapter in the agency's regulatory turbulence. His exit reveals deeper structural tensions in how the FDA balances speed with rigor, and what it means for biotech's future.

Policy

FDA Drops Two-Trial Dogma: Historic Policy Shift Could Accelerate Drug Approvals and Transform Biotech Development

In what may be the most significant regulatory development for biotech in a decade, the FDA announced on February 18, 2026, that it is abandoning its long-standing expectation of two pivotal clinical trials for new drug approvals. Moving forward, the agency will require only one adequate and well-controlled clinical trial

Pharmaceuticals

FDA's Unprecedented Rejection of Moderna's mRNA Flu Vaccine Sends Shockwaves Through Biotech Industry

The FDA's unprecedented rejection of Moderna's mRNA flu vaccine application marks a dramatic departure from traditional regulatory practices and raises profound questions about the future of vaccine innovation in America.

Biotechnology

ErlySign Achieves FDA Breakthrough: Revolutionary Saliva Test Could Transform Oral Cancer Detection

Nagpur-based ErlySign receives FDA Breakthrough Device Designation for its innovative saliva-based oral cancer detection kit, marking a significant milestone in non-invasive cancer diagnostics.

Pharmaceuticals

Pharming Group Faces Regulatory Setback as FDA Issues Complete Response Letter for Pediatric APDS Treatment

Pharming Group announced that the FDA issued a Complete Response Letter for its supplemental application to expand Joenja treatment to children aged 4-11 with APDS, citing concerns about dosing precision and manufacturing quality.

Biotechnology

FDA Accepts First-Ever Quality Control Standard for Mesenchymal Stromal Cells, Setting New Benchmark for Cell Therapy Industry

The FDA's acceptance of Tasly's 3P Characterization of MSCs Assay marks the first FDA-recognized quality control standard for mesenchymal stromal cells, establishing a new benchmark for the cell therapy industry and accelerating the path to consistent, safe, and effective MSC-based therapies.

Pharmaceuticals

Year-End FDA Rejections Deliver Harsh Reality Check to Sanofi and Corcept

The final days of 2025 delivered unwelcome surprises to two pharmaceutical companies as the FDA issued complete response letters rejecting drug applications from both Sanofi and Corcept Therapeutics. These unexpected regulatory setbacks underscore the unpredictable nature of drug approval processes and highlight how even promising therapies with strong clinical data