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FDA clears Amgen’s Bkemv as first biosimilar of Soliris

The US FDA has approved the first biosimilar version of AstraZeneca/Alexion’s Soliris therapy for paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemi

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ATS: Amgen, AZ say data backs Tezspire’s role in COPD

Amgen and AstraZeneca have said their severe asthma therapy Tezspire could have a role to play in chronic obstructive pulmonary disease (COPD) – a key target indication fo

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Amgen adds BiTE to its cancer range as FDA clears Imdelltra

Amgen has doubled its range of bispecific T-cell engager (BiTE) drugs with the FDA approval of tarlatamab for advanced small cell lung cancer (SCLC) after a priority revie

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Uniquity Bio emerges with $300m for MSD immunology drug

New start-up Uniquity Bio arrived on the scene today with $300 million in funding from Blackstone Life Sciences and a clinical-stage inflammation and immunology drug licen

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Sandoz gets first FDA OK for denosumab biosimilars

Sandoz has claimed the first FDA approvals for biosimilars of Amgen’s blockbuster bone disease therapy denosumab, but has not said when it plans to launch them onto the US

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MHRA okays first drug under new mutual recognition scheme

A new formulation of Amgen’s cancer treatment Xgeva is the first to be approved in the UK under a new procedure designed to speed up access to new therapies.

FDA clears Amgen’s Bkemv as first biosimilar of Soliris

ATS: Amgen, AZ say data backs Tezspire’s role in COPD

Amgen adds BiTE to its cancer range as FDA clears Imdelltra

Uniquity Bio emerges with $300m for MSD immunology drug

Sandoz gets first FDA OK for denosumab biosimilars

MHRA okays first drug under new mutual recognition scheme

Agios mulls early FDA filing for sickle cell therapy

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