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Regulatory Affairs

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UK and Singapore Unveil MHRA–HSA Innovation Corridor to Speed Patient Access to New Health Technologies

The corridor creates one early engagement route with both regulators for coordinated scientific advice.

MediNatura Recalls ReBoost Nasal Spray Lot Over Mold and Bacterial Contamination

FDA Opens Safety Review of Infant RSV Antibody Drugs Beyfortus and Enflonsia

FDA Class III Recall Targets 11,136 Bottles of Ziac Over Trace Ezetimibe Contamination

Structure Therapeutics' Oral GLP-1 Posts Up to 15% Placebo-Adjusted Weight Loss as Company Prepares Phase 3

Ianalumab Plus Eltrombopag Extends Disease Control in Phase 3 ITP Study Published in NEJM

FDA Qualifies First AI Tool for MASH Drug Trials

Epcoritamab Added to R2 Yields Large Efficacy Gains in Relapsed Follicular Lymphoma

Dyne’s DMD Drug Hits Primary Endpoint in DELIVER REC, Shows Functional Gains

KOMET-007 Shows 600 mg Ziftomenib Plus Venetoclax/Azacitidine Achieves Deep Remissions in NPM1‑Mutated AML

FDA Approves One-Time Intrathecal Gene Therapy Itvisma for Older SMA Patients

FDA Grants Breakthrough Therapy Designation to Incyte’s CALR‑Targeting Antibody as ASH Data Show Early Efficacy in Myelofibrosis

Recalls Expand for Abbott FreeStyle Libre 3 Sensors Over False Low Readings

FDA Approves Breyanzi for Marginal Zone Lymphoma After Two or More Therapies

FDA Issues Early Alert on Certain FreeStyle Libre 3 Sensors After False Low Readings Linked to Harm

FDA Meeting Minutes Undercut uniQure’s Plan to File Huntington’s Gene Therapy for Approval

FDA Names Tracy Beth Høeg Acting CDER Director as OTC Drugs Chief Is Reassigned

Capricor’s HOPE-3 Trial Reports Cardiac and Muscle Gains in Duchenne Muscular Dystrophy

Belite Bio’s Tinlarebant Cuts Stargardt Lesion Growth 36% in Phase 3 Trial

FDA Accepts Sonrotoclax NDA, Grants Priority Review for Relapsed Mantle Cell Lymphoma