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Emergent BioSolutions

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Novartis’ Cosentyx receives FDA approval for hidradenitis suppurativa

The decision makes Cosentyx the first biologic treatment approved for HS in nearly a decade

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bluebird bio to sell FDA priority review voucher for $103m

The company previously sold its second voucher to Bristol Myers Squibb for $95m

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FDA approves Santhera’s Duchenne muscular dystrophy drug Agamree

The rare muscle-wasting disorder is estimated to affect one in 3,500 male births worldwide

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Eli Lilly’s Omvoh granted FDA approval for ulcerative colitis

Inflammatory bowel disease is estimated to affect nearly one in every 100 people in the US

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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

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Pfizer’s pentavalent meningococcal vaccine granted FDA approval

Penbraya helps protect against the five most common meningococcal serogroups

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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

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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

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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

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

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

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