regulatory approval

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Stéphane Bancel, Moderna's chief executive

Moderna's RSV shot gets US nod for use in younger adults

The label for Moderna's RSV vaccine mResvia has been expanded to include adults aged 18 and over in the US, but will that lead to an uptick in sales?

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FDA clears Nuvation's first product Ibtrozi, for lung cancer

Nuvation is set to launch its first commercial product after the FDA approved its ROS1 inhibitor Ibtrozi as a treatment for ROS1-positive lung cancer.

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Beyfortus now has a direct rival after FDA OK for Enflonsia

MSD could soon enter the US market for drugs used to protect infants from RSV infections, setting up a rivalry with AstraZeneca/Sanofi's Beyfortus.

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George Medicines chief executive Mark Mallon

George gets FDA nod for first blood pressure triple therapy

George Medicines' Widaplik can address key challenges in current hypertension treatment, according to the UK drugmaker's CEO.

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AZ claims EU approval for new Calquence regimens in CLL

AstraZeneca has secured a key approval for its BTK inhibitor Calquence in Europe, currently facing a strong challenge from BeOne's rival Brukinsa.

News

GSK claims first approval for Nucala in COPD

GSK gets FDA approval for Nucala in COPD, setting up a marketing tussle with Sanofi/Regeneron's Dupixent.

Moderna's RSV shot gets US nod for use in younger adults

FDA clears Nuvation's first product Ibtrozi, for lung cancer

Beyfortus now has a direct rival after FDA OK for Enflonsia

George gets FDA nod for first blood pressure triple therapy

AZ claims EU approval for new Calquence regimens in CLL

GSK claims first approval for Nucala in COPD

Repligen builds in cell therapy with $1.5bn BioLife takeover

Discover a new era of healthcare panel engagement: Grounded ...

regulatory approval

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