Biotechnology
Structure Therapeutics' aleniglipron showed 15% weight loss in Phase 2 trials, delivering injectable-like efficacy in pill form and reshaping the competitive landscape for oral GLP-1 obesity drugs.
Biotechnology
Sana Biotechnology's 14-month follow-up data shows transplanted insulin-producing cells surviving and functioning without immunosuppression—a potential breakthrough in type 1 diabetes treatment.
Pharmaceuticals
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
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.
Biotechnology
BioNTech's co-founders are stepping down to launch a new mRNA startup. What does this mean for the company's oncology pipeline and the future of mRNA technology?
Pharmaceuticals
On March 9, 2026, Ipsen announced the immediate voluntary withdrawal of Tazverik (tazemetostat) from all markets worldwide. The decision, triggered by safety signals from the ongoing SYMPHONY-1 confirmatory trial, marks one of the more consequential drug withdrawals in recent oncology history. Not because of the commercial stakes, which were
Policy
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.
Markets
Eli Lilly's new Employer Connect platform lets workers buy Zepbound at $449/month, bypassing insurers entirely. It is a bold bet that pharma companies can rewrite the rules of drug distribution before compounders and insurers do it for them.
Biotechnology
Zorevunersen becomes the first therapy to show disease modification in Dravet syndrome, offering hope for families through improved seizure control and developmental outcomes.
Pharmaceuticals
In a significant regulatory achievement that could transform treatment options for millions of patients worldwide, Johnson & Johnson announced on March 3, 2026, that the U.S. Food and Drug Administration has granted Fast Track designation to nipocalimab for the treatment of adults with systemic lupus erythematosus (SLE). This milestone
Biotechnology
Larimar Therapeutics announced FDA Breakthrough Therapy Designation for nomlabofusp, the first protein replacement therapy for Friedreich's ataxia, opening accelerated pathways for this devastating rare disease.
Pharmaceuticals
In a significant regulatory achievement that could transform treatment for one of hematology's most challenging conditions, Takeda Pharmaceutical and Protagonist Therapeutics announced on March 2, 2026, that the FDA has accepted their New Drug Application (NDA) and granted Priority Review for rusfertide, a first-in-class hepcidin mimetic