Regulatory Approvals

The decision expands Imfinzi’s bladder cancer footprint beyond its earlier approval in muscle-invasive bladder cancer (MIBC), where it is used with chemotherapy agents’ gemcitabine and cisplatin before surgery and as a monotherapy afterward.

Phesgo, manufactured by Roche, contains a combination of Pertuzumab and Trastuzumab and is used in the treatment of specific types of breast cancer.

If approved, MAVIRET would become one of the few therapies in the European Union indicated for both acute and chronic HCV infection.

Wegovy® 7.2 mg is already available in the European Union for adults with obesity through three separate 2.4 mg injections administered weekly.

The treatment is approved in the United States for adults and pediatric patients aged six months and older, making it one of the few targeted therapies available for this condition.

Regulators approved the drug as an additional therapy for patients whose blood pressure remains uncontrolled despite using standard antihypertensive medicines.

The approval applies to adolescents and adults weighing at least 35 kilograms who have haemophilia A with factor VIII inhibitors or haemophilia B with factor IX inhibitors.

NICE recommended Imfinzi for adults whose stomach cancer has not spread extensively and can be removed through surgery, including gastric and gastro-oesophageal junction cancers that physicians frequently diagnose at advanced stages.

Urodynamics assesses how the bladder, urethra, and sphincters store and release urine to identify causes of leakage or obstruction.