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- PMLiVE

Takeda’s subcutaneous Entyvio approved by FDA as Crohn’s disease maintenance therapy

Inflammatory bowel disease affects around ten million people worldwide

- PMLiVE

Roche’s ALK inhibitor Alecensa receives FDA approval to treat early-stage NSCLC

Approximately half of all patients with early lung cancer experience cancer recurrence following surgery

- PMLiVE

Roche receives FDA breakthrough device designation for Alzheimer’s disease blood test

Around 55 million people globally are living with dementia, which is estimated to rise to 139 million by 2050

- PMLiVE

Sanofi presents promising results for investigational frexalimab in relapsing forms of MS

Approximately 85% of patients are initially diagnosed with relapsing forms of the neurological disease

- PMLiVE

FDA establishes new CDER centre focused on promoting clinical trial innovation

The C3TI will give internal and external parties easier access to information on clinical trial innovation

- PMLiVE

AstraZeneca’s Fasenra receives FDA approval for paediatric patients with severe asthma

Severe eosinophilic asthma causes inflammation in the lungs and airways of patients

- PMLiVE

Vertex to expand autoimmune and inflammatory disease pipeline with $4.9bn Alpine acquisition

The company will gain rights to Alpine’s lead molecule, povetacicept, to treat IgA nephropathy

- PMLiVE

Sanofi announces UK launch of inactivated rabies vaccine Verorab for all age groups

The rare neurotrophic virus is responsible for an estimated 59,000 global deaths every year

- PMLiVE

New study reveals discrepancies in FDA accelerated approval process for cancer drugs

The study looked at 46 different cancer drugs that received accelerated approvals between 2013 and 2017

- PMLiVE

BMS and 2seventy’s multiple myeloma therapy Abecma receives expanded FDA approval

More than 35,700 new cases of the disease are expected to be diagnosed in the US this year

- PMLiVE

J&J and Legend’s Carvykti approved by FDA for expanded multiple myeloma use

The cell therapy is the first and only BCMA-targeted therapy to be approved for this condition as early as first relapse

- PMLiVE

AstraZeneca/Daiichi Sankyo’s Enhertu granted FDA accelerated approval for solid tumours

The ADC has been authorised to treat adults with unresectable or metastatic HER2-positive tumours

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