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Eli Lilly’s Alzheimer’s drug unanimously endorsed by FDA panel of experts

The company is seeking approval of donanemab to treat patients with early stages of the disease

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Almirall’s Klisyri receives expanded FDA approval to treat actinic keratosis

The precancerous condition is responsible for an estimated 60% of all squamous cell carcinoma cases

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GSK’s RSV vaccine Arexvy approved by FDA for use in adults aged 50 to 59 years

The decision comes just over a year after the FDA approved Arexvy for use in adults aged 60 years and older

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Amgen’s interchangeable Soliris biosimilar Bkemv approved by FDA for rare blood disorders

Bkemv has been authorised to treat paroxysmal nocturnal haemoglobinuria and atypical haemolytic uraemic syndrome

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Sanofi’s multiple myeloma treatment Sarclisa accepted for FDA priority review

The second most common haematologic malignancy is responsible for more than 180,000 new global diagnoses every year

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Amgen’s Imdelltra granted FDA accelerated approval to treat small cell lung cancer

More than 234,000 new cases of lung cancer are expected to be diagnosed in the US this year

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Sanofi and Sobi’s Altuviiio label updated by FDA with expanded paediatric data in haemophilia A

The therapy’s weekly dosing has a half-life of up to four times longer than current factor VIII therapies

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Bristol Myers Squibb’s Breyanzi granted FDA accelerated approval for follicular lymphoma

The disease accounts for up to 30% of all non-Hodgkin lymphoma cases

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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

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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

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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

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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

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