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- PMLiVE

Amgen

Roche Basel Switzerland

FDA approval for Roche diagnostic solid tumour test

Test will identify which patients could benefit from GSK immunotherapy.

- PMLiVE

Amgen pays $900m upfront to acquire Teneobio’s antibody assets, R&D technologies

Amgen will gain antibody technologies designed to discover and develop new molecules with broad applications across therapeutic areas

- PMLiVE

FDA leaders offer perspective on accelerated approval of Biogen’s Aduhelm

Leaders maintain that Aduhelm fits into the regulatory paradigm of the FDA’s accelerated approval pathway

- PMLiVE

FDA questions safety profile of AZ, FibroGen’s anaemia drug roxadustat

AZ and FibroGen are aiming for approval of roxadustat in anaemia caused by chronic kidney disease

- PMLiVE

FDA acting commissioner Janet Woodcock requests independent review of Aduhelm approval

Approval of Biogen's Alzheimer's disease treatment has raised concerns over FDA staff interactions with the company

- PMLiVE

Pfizer, BioNTech eye US approval for COVID-19 booster dose

Companies plan to request an emergency use authorisation from the FDA for the booster dose in August

- PMLiVE

FDA grants priority review for AZ, Amgen’s tezepelumab for asthma

Drug 'has the potential to transform treatment for a broad population of severe asthma patients'

- PMLiVE

US Supreme Court rebuffs Sandoz’s Enbrel biosimilar patent case

Amgen will retain market exclusivity on blockbuster arthritis drug until 2029

- PMLiVE

AZ, Amgen file first-in-class asthma drug with the FDA

Submission is based on positive results from the companies’ PATHFINDER clinical programme

- PMLiVE

Amgen plans acquisition of Rodeo Therapeutics

Deal could be worth over $700m including potential future milestone payments

- PMLiVE

FDA advisory committee to review oncology accelerated approvals

Review comes after voluntary indication withdrawals for a number of cancer therapies

- PMLiVE

Amgen adds to oncology pipeline with $1.9bn Five Prime Therapeutics acquisition

Five Prime's pipeline includes potentially first-in-class anti-FGFR2b antibody bemarituzumab

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