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FDA Authorizes Early Access to Daraxonrasib for Pancreatic Cancer Patients

The decision follows trial results showing the oral drug roughly doubled survival versus chemotherapy.

FDA Panel Rejects AstraZeneca Breast Cancer Drug, Backs Prostate Therapy

Moderna Beats Q1 Revenue Forecast on Stronger Overseas COVID Vaccine Sales

FDA Launches First Real-Time Clinical Trial Pilot With AstraZeneca and Amgen

EMA Validates Astellas Bid to Add Padcev–Keytruda Combo for Perioperative Muscle-Invasive Bladder Cancer

Viatris Recalls One Lot of Xanax XR Nationwide After Tablets Fail FDA Dissolution Test

FDA Orders Post-Approval Safety Studies for Lilly’s Foundayo Weight-Loss Pill

Blood Test Detects Alzheimer’s Risk Years Before PET Scans

FDA Grants Priority Review to Ifinatamab Deruxtecan for Pretreated Small Cell Lung Cancer

FDA Rejects Replimune’s Melanoma Virus Therapy Again for Insufficient Evidence

FDA Flags Recall of 3.1 Million Store-Brand Eye Drops Over Sterility Concerns

3.1 Million Bottles of Store-Brand Eye Drops Recalled for Sterility Concerns

Pfizer and BioNTech Halt U.S. COVID Vaccine Trial for 50–64-Year-Olds Over Slow Enrollment

FDA Flags 76 Liver Injuries Linked to Amgen’s Tavneos, Urges Tight Monitoring

FDA Approves Awiqli, First Once-Weekly Basal Insulin for Type 2 Diabetes

FDA Grants Accelerated Approval to Avlayah for Neurologic Manifestations of Hunter Syndrome

Pfizer, Valneva Seek Approval for Lyme Vaccine After >70% Efficacy in Phase 3

FDA Approves Nivolumab Plus AVD as First-Line Therapy for Advanced Hodgkin Lymphoma

For Third Time, FDA Rejects Aldeyra’s Dry-Eye Drug Reproxalap Over Efficacy

FDA Expands GSK’s Arexvy to High-Risk Adults 18–49, Completing Trio of RSV Vaccines for Younger At‑Risk Group