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- PMLiVE

tovorafenib

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Biogen and Eisai announce rolling FDA submission for injectable version of Alzheimer’s drug

The Leqembi SC autoinjector could reduce the need for hospital visits and nursing care compared to IV administration

- PMLiVE

Roche announces FDA approval of self-collection solution for HPV screening

More than 13,000 people are diagnosed with cervical cancer every year in the US

- PMLiVE

Pfizer/Genmab’s Tivdak granted full FDA approval for recurrent or metastatic cervical cancer

It is estimated that more than 13,960 new cases of invasive cervical cancer were diagnosed in the US last year

- PMLiVE

Pfizer’s one-time haemophilia B therapy Beqvez granted FDA approval

More than 38,000 people worldwide are currently affected by the rare genetic bleeding disorder

- 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

- PMLiVE

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

- 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

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

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