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FDA Demands Placebo-Controlled Trial for UniQure’s Huntington’s Gene Therapy

A senior official publicly rejected UniQure’s external-control evidence to set expectations for randomized data.

Zealand Plunges as Roche Obesity Drug Posts 10.7% Weight Loss With Placebo‑Like Tolerability

Novo’s Triple-Hormone Obesity Drug UBT251 Hits 19.7% Mean Weight Loss in China Phase 2

FDA Approves First All-Oral, Fixed-Duration First-Line CLL/SLL Regimen: Calquence Plus Venetoclax

FDA Rejects Disc Medicine’s Bitopertin for EPP After Questioning Surrogate Endpoint

Asundexian Cuts Recurrent Stroke 26% Without More Major Bleeding in Phase III

Medicare GLP-1 Use Surges as CMS Advances Coverage Expansion and Lilly Eyes Q2 Pill Launch

Roche’s CT-388 Shows Up to 22.5% Placebo-Adjusted Weight Loss in Phase 2 as Phase 3 Nears

Sarepta Reports 3-Year EMBARK Data Showing Elevidys Slows Duchenne Progression

Sanofi Pushes Amlitelimab Toward 2026 Filings After Mixed Phase 3 Readouts

Valneva Pulls U.S. Filings for Chikungunya Vaccine as FDA Halts Trials Over Safety Review

FDA Delays Two Drugs in National Priority Voucher Program After Safety, Efficacy Flags

Lilly Reports Zepbound Plus Taltz Beat Taltz Alone in Psoriatic Arthritis Trial

FDA Approves First Oral GLP-1 for Obesity as Novo’s Wegovy Pill Sets January U.S. Launch

Takeda’s AI-Assisted Psoriasis Pill Succeeds in Phase 3, Outperforms Otezla

Lilly Files Orforglipron Obesity Pill With FDA After Trial Shows Weight-Loss Maintenance

FDA Adds Brain Tumor Warning to Two Depo‑Provera Injections

Lilly’s Daily Obesity Pill Sustains Weight Loss After Switch From Wegovy or Zepbound

FDA Clears Enhertu-Perjeta Combo for First-Line HER2-Positive Metastatic Breast Cancer

Sanofi Ends PPMS Bid After Tolebrutinib Fails Phase 3 as FDA Delays Review for nrSPMS