Bright Minds’ BMB-101 Hold Exposes a Recurring Failure in Preclinical-to-IND Translation
FDA's partial hold on Bright Minds' BMB-101 for pediatric epilepsy, citing mouse toxicity and inadequate data, reveals a preclinical...
A Patient Died in BMS’s MS CAR-T Trial. No One Can Say Why.
A Phase 1 multiple sclerosis patient died 44 days after a zola-cel infusion. BMS says confounding factors prevent it...
The Dystrophin Standard: How a 1% Biomarker Signal Became a $967 Million Accelerated Approval Precedent
FDA granted four DMD antisense oligonucleotide accelerated approvals on ~1 percentage-point dystrophin increases. With $967M in annual revenue on...
Three of Four Deaths Were Called Unrelated. The FDA Still Saw a Signal
Newron's investigators assessed three of four evenamide deaths as unrelated. The FDA, looking at the same events pooled across...
Novo’s Denecimig Got a Green Light From Clinicians and a Red Light From an Inspector: Who Failed?
FDA extended its denecimig BLA review over unnamed facility remediation failures, exposing the manufacturing blind spot that nearly every...
AB Science’s “Calendar Update” Is a GCP Inspection Disclosure in Disguise
AB Science buried a five-inspector "for cause" GCP inspection inside a financial calendar update. Masitinib's ALS trial and three...
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...