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- 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

Pfizer announces FDA approval for Braftovi/Mektovi combination in lung cancer

Non-small cell lung cancer accounts for approximately 85% of all lung cancers cases

- 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

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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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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

- PMLiVE

Pfizer’s Abrysvo RSV vaccine recommended by US CDC for infants

The recommendation allows Abrysvo to be given to pregnant women from 32 to 36 weeks

- PMLiVE

Pfizer’s Litfulo approved by EC for adults and adolescents with severe alopecia areata

The autoimmune disease affects approximately 147 million people globally

- PMLiVE

Date set for EU antitrust regulators to decide on Pfizer’s $43bn Seagen acquisition

The proposed transaction would mark a significant boost to the US pharma’s oncology pipeline

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