Biohaven Advanced BHV-7000 to Pivotal Trials Without Answering a Question the FDA Requires Every Sponsor to Answer
FDA's Sept. 4 partial hold on Biohaven's opakalim exposes a metabolite characterization gap that ICH M3(R2) and FDA's 2021...
FDA Enforcement
Regenxbio’s Second Clinical Hold in Eight Months Exposes a Safety Monitoring System That Was Never Rebuilt After the First One
FDA hits RGX-121 with a second clinical hold in 2026 over spine MRI findings in 5 patients—revealing systemic monitoring...
The EU Just Revoked Tavneos. What Did FDA Know During the Parallel Review?
EMA revoked Tavneos (avacopan) in August 2026 over GCP breaches in the pivotal ADVOCATE trial. FDA approved the same...
Scholar Rock’s Apitegromab Filing Exposes the CMO Due Diligence Gap That Keeps Burning Sponsors
Scholar Rock dropped Novo's Catalent plant from its SMA drug refiling after an OAI inspection. The compliance rot was...
Three Strikes, Same Deficiency: How Elevar Therapeutics Turned a Solvable Manufacturing Problem Into a Patient Crisis
Elevar Therapeutics received its third FDA CRL in two years for rivoceranib plus camrelizumab in liver cancer, each citing...
Genzyme Ireland’s 483 Is Not a Manufacturing Story. It’s a Sponsor Oversight Indictment.
FDA's June 2026 warning letter to Genzyme Ireland over Altuviiio manufacturing exposes how post-approval CGMP oversight collapses at the...
Sobi’s Gout CRL Is a Third-Party Manufacturing Indictment — And the Industry Wrote the Script
FDA issued Sobi a CRL for NASP on June 26, 2026, citing third-party manufacturing failures. Here's the operational breakdown...
Jazz and PharmaMar Just Ran Out of Runway: Zepzelca’s Confirmatory Failure Is an Accelerated Approval System Under Stress
Zepzelca's Phase 3 LAGOON trial missed overall survival in SCLC—Jazz's second confirmatory failure, six years after a 105-patient single-arm...
Zynlonta’s 3-to-1 Death Ratio Is the Accelerated Approval System Grading Its Own Homework
ADC Therapeutics' LOTIS-5 trial shows 13.2% fatal events vs. 4.6% in controls—a 3:1 death imbalance that exposes accelerated approval's...
Aardvark’s Clinical Hold Isn’t Bad Luck — It’s a Pre-Clinical Characterization Failure
FDA placed a full clinical hold on Aardvark's ARD-101 after a cardiac event in a healthy volunteer. Here's what...