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...
Fresenius Got a Warning Letter Six Months After the Complaints Started. That Gap Is the Real Problem.
FDA's August 2026 warning letter to Fresenius Kabi's Ogden, Utah plant exposes how sponsor oversight of CMOs fails long...
Orexo’s $4 Million DOJ Settlement Is Deliberately Vague — and That Vagueness Is the Story
Orexo AB settled a 6-year DOJ opioid-marketing investigation for $4M, but the press release names no conduct, no victims,...
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...
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...