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FDA Extends Review of AstraZeneca’s Camizestrant

The agency requested extra analyses over concerns about late-stage trial design, with advisers citing immature long-term outcomes.

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Apnimed Pill Cuts Sleep Apnea Events in Phase 3 as Company Seeks FDA Approval

FDA Places Full Clinical Hold on Aardvark’s ARD-101 Prader–Willi Trials

FDA Approves Bizengri for NRG1 Fusion-Positive Cholangiocarcinoma

FDA Authorizes Early Access to Daraxonrasib for Pancreatic Cancer Patients

FDA Panel Rejects AstraZeneca Breast Cancer Drug, Backs Prostate Therapy

Moderna Beats Q1 Forecast as Overseas COVID Shot Sales Rebound

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