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...
Capricor’s Duchenne AdCom Didn’t Fail on Science. It Failed on Statistics.
FDA's CTGTAC voted 9-3 against Capricor's deramiocel on July 30, 2026. The science wasn't the problem. The statistical methodology...
Capricor’s Deramiocel Briefing Is a Masterclass in How Not to Define an Endpoint
FDA's July 27 briefing document for Deramiocel (BLA 125842) contradicts Capricor's Phase 3 efficacy claims ahead of tomorrow's AdCom...
CMS Just Declared War on RPM Vendors. Clinical Trial Sponsors Should Be Paying Attention.
CMS's proposed 2027 fee schedule would ban Medicare payments for third-party RPM vendors after OIG flagged $536M in billing...
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...
Zoll Medical’s FDA Warning Letter Reveals the QC Failure Sponsors Keep Funding
FDA's April 2026 warning letter to Zoll Medical exposes quality control and MDR violations at a cardiopulmonary device maker...
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...