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Regeneron's Libtayo stakes out new territory in skin cancer

Regeneron's Libtayo has become the first checkpoint inhibitor to be cleared by the FDA as an adjuvant treatment for cutaneous squamous cell carcinoma.

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Image of J&J baby powder as originally sold

J&J on the hook for $966m damages in latest talc lawsuit

Johnson & Johnson has suffered a setback in its long-running legal defence against claims its talc products cause cancer.

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Boehringer bags FDA okay for new pulmonary fibrosis drug

Boehringer's successor to blockbuster IPF therapy Ofev has been approved by the FDA as Jascayd, but will the new drug be a commercial success?

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Pills piled together in the shape of the USA

FDA pilots fast-track scheme for US-made generics

In another effort to boost domestic drug manufacturing, the FDA is piloting fast-track reviews for generics tested and made in US facilities.

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Rocket aborts FDA filing for Fanconi gene therapy

Rocket Pharma has withdrawn a filing in the US for its experimental gene therapy for Fanconi anaemia, but may consider partnering the programme.

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Jazz, Roche combo cleared by FDA for lung cancer

Can FDA approval of Jazz Pharma's Zepzelca in a combination regimen for extensive-stage small cell lung cancer return sales of the drug to growth?

Regeneron's Libtayo stakes out new territory in skin cancer

J&J on the hook for $966m damages in latest talc lawsuit

Boehringer bags FDA okay for new pulmonary fibrosis drug

FDA pilots fast-track scheme for US-made generics

Rocket aborts FDA filing for Fanconi gene therapy

Jazz, Roche combo cleared by FDA for lung cancer

Otsuka grows in neuroplastogens with $1.225bn Transcend buy

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