Pharmafile Logo

ZS-9

- PMLiVE

AstraZeneca’s Enhertu combination approved by FDA for HER2-positive breast cancer

Around one in five breast cancer cases are HER2-positive

- PMLiVE

FDA approves first gene therapy for Wiskott-Aldrich syndrome

Symptoms of the rare disease include bleeding, eczema and frequent infections

- PMLiVE

FDA launches TEMPO digital health pilot

Digital technologies can improve remote patient care for those with chronic diseases

- PMLiVE

Richard Pazdur, FDA’s drug evaluation chief, to leave FDA just weeks into new role

Pazdur was previously head of the FDA’s Oncology Center of Excellence

- PMLiVE

AstraZeneca’s Imfinzi receives FDA approval for gastric and gastro-oesophageal cancers

In 2022, nearly one million new patients were diagnosed with gastric cancer

- PMLiVE

Merck KGaA given FDA Fast Track designation for generalised myasthenia gravis drug

Cladribine capsules could become the first ever oral treatment for gMG

- PMLiVE

AstraZeneca announces $2bn investment in US manufacturing

The new and expanded facilities will support production of rare disease drug treatments

- PMLiVE

AstraZeneca reports positive results from rare disease trial

HES is a group of rare disorders characterised by persistently elevated levels of white blood cells

- PMLiVE

Johnson & Jonson secures FDA approval for multiple myeloma treatment

Support for first and only high-risk smouldering multiple myeloma treatment came from positive phase 3 trial results

- PMLiVE

AstraZeneca reports positive results from phase 3 blood pressure trial

The study demonstrated reduction in systolic blood pressure compared to placebo in patient with hypertension

- PMLiVE

GSK’s Blenrep approved by FDA for multiple myeloma

Approval supported by positive results from phase 3 trial

- PMLiVE

AstraZeneca to invest $4.5bn in US manufacturing facility

The investment will further support the company’s growing oncology pipeline

Subscribe to our email news alerts

Latest content

Latest intelligence

Quick links