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- PMLiVE

FDA approves Servier’s Tibsovo as first targeted therapy for rare blood cancer

Approximately 16,000 people in the US are diagnosed with myelodysplastic syndromes every year

- PMLiVE

Pfizer’s pentavalent meningococcal vaccine granted FDA approval

Penbraya helps protect against the five most common meningococcal serogroups

- PMLiVE

FDA approves UCB’s inflammatory disease drug Bimzelx for plaque psoriasis

More than 7.5 million adults in the US are affected by some form of the chronic inflammatory condition

- PMLiVE

Merck’s Keytruda granted FDA approval for expanded use in lung cancer

The approval marks the sixth non-small cell lung cancer indication for the anti-PD-1 therapy

- PMLiVE

Bristol Myers Squibb’s Opdivo approved by FDA for expanded melanoma use

More than 97,000 cases of melanoma are expected to be diagnosed in the US in 2023

- PMLiVE

FDA establishes new advisory committee to provide expertise on digital health

The committee will consist of individuals with technical and scientific expertise from diverse disciplines and backgrounds

- PMLiVE

Amgen presents new findings for Uplizna in neuromyelitis optica spectrum disorder

The rare and debilitating disease affects approximately one to ten per 100,000 people

- PMLiVE

Novavax’s updated COVID-19 vaccine approved by FDA for emergency use

Individuals aged 12 years and older will be eligible to receive the company's updated vaccine

regeneron headquarters

Regeneron’s odronextamab granted FDA priority review for non-Hodgkin lymphoma

The regulator is expected to make a decision on the drug by the end of March 2024

Biogen Idec building

Biogen’s Actemra biosimilar approved by FDA to treat adult and paediatric arthritis

Tofidence is now the first biosimilar referencing Actemra to gain approval from the US regulator

- PMLiVE

GSK’s Ojjaara receives FDA approval to treat myelofibrosis patients with anaemia

Myelofibrosis is a rare blood cancer affecting approximately 25,000 patients in the US

- PMLiVE

FDA boosts collaboration with manufacturers to overcome ongoing cancer drug shortages

The supply of cisplatin, carboplatin and methotrexate has nearly halved in the past year

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