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- PMLiVE

cemiplimab

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Biogen and Eisai announce FDA submission for early Alzheimer’s treatment

The licence application for the treatment of mild cognitive impairment due to Alzheimer’s disease was made as part of the accelerated approval pathway programme

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AstraZeneca’s Imfinzi plus chemotherapy accepted for Priority Review in the US

The drug combination offers biliary tract cancer patients a new treatment option

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FDA limits use of Janssen’s COVID-19 vaccine

Authorisation of Janssen COVID-19 vaccine restricted among certain people following analysis and evaluation

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Sanofi launches new funding foundation

Foundation S is a philanthropic endowment fund aimed at encouraging healthier lives for future generations

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Sanofi and McLaren Racing come together to maximise performance and operational excellence

The partnership will complement Sanofi’s R&D pipeline, which has 25 new launches planned over the next five years

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FDA grants Prothena fast-track designation for next-generation Alzheimer’s disease therapy

Approximately 50 million people worldwide are estimated to be living with Alzheimer’s disease or other dementias

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FDA approves Alexion’s Ultomiris for generalised myasthenia gravis

gMG is a rare autoimmune neuromuscular disease that causes a loss of muscle function and severe weakness

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FDA approves COVID-19 treatment for those under the age of 12

Veklury is currently the only COVID-19 treatment approved for this age group

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Sanofi’s Rezurock results show positive patient outcomes

Pooled analysis of chronic graft-versus-host disease treatment demonstrates organ clinical responses correlated with meaningful changes

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Sanofi begins construction on the first of two Evolutive Vaccine Facilities in Singapore

The two sites aim to improve pandemic preparedness and will have an estimated cost of $1.3bn over the next five years

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Kite’s new CAR T-cell therapy manufacturing facility given the go-ahead by the FDA

The site in the US will produce CAR T-cell therapies for patients with blood cancers

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Enhertu to provide patients with vital targeted therapy option

Therapy receives FDA priority review as patients with HER2-mutant metastatic non-small cell lung cancer seek alternative treatment

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