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- PMLiVE

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- PMLiVE

Novartis’ Lutathera receives FDA approval to treat neuroendocrine tumours in paediatric patients

The incidence of neuroendocrine tumours has increased over the past several decades

- PMLiVE

FDA grants Day One’s Ojemda accelerated approval for paediatric low-grade glioma

The type 2 RAF inhibitor is the first and only one approved in the US to treat this patient population

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FDA approves ImmunityBio’s Anktiva for non-muscle invasive bladder cancer

NMIBC accounts for up to 80% of bladder cancer cases, the tenth most commonly diagnosed cancer globally

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

Inflammatory bowel disease affects around ten million people worldwide

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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

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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

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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

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

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

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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

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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

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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

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