FDA Approval & Clinical Trial Enrollment Watch

Track new treatments for US patients. Report only confirmed, source-backed items from the last 7 days and the coming 14 days: FDA approvals, complete response letters and label expansions for drugs, biologics and devices with the condition and patient population; upcoming PDUFA dates and advisory committee meetings within 14 days; accelerated approval withdrawals or confirmatory trial failures; expanded access and compassionate use program openings; phase 3 trial enrollment openings on ClinicalTrials.gov for cancer, Alzheimer's, Parkinson's, ALS, diabetes, obesity, autoimmune, cardiovascular and rare diseases with US site locations and eligibility summary; and manufacturer patient assistance and copay program launches with income limits. Prefer FDA, ClinicalTrials.gov, NIH, manufacturer and society sources; ignore preclinical claims and stock promotion. Put the drug and the condition first in the title. Use high severity for a first-in-class approval, an approval withdrawal, or a trial enrollment window closing within 30 days. Return no more than 8 findings. Push each as a finding with a title, a two-sentence summary, sections for what it is, who is eligible, the date or deadline, what to ask a doctor, and the source link. Note that findings are informational and not medical advice. If nothing qualifies, push nothing and submit the run receipt.