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Tag: asthma drug


FDA, Regulations

RAPT hit by FDA clinical hold on eczema, asthma drug

February 21, 2024

Via: Pharmaphorum

The stock plunged almost 74% after the announcement of a “serious adverse event” – a case of liver failure – in the trial involving patients with atopic dermatitis, also known as eczema. RAPT said the FDA had “verbally notified” it […]


News

EU clears AstraZeneca’s new-form severe asthma drug Tezspire

January 13, 2023

Via: Pharmaphorum

The green light for the pre-filled, single-use pen version of Tezspire (tezepelumab) comes just four months after the TSLP inhibitor became the first biologic therapy for severe asthma to be cleared in the EU for use in all patients, and […]


FDA, News, Regulations

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

May 11, 2021

Via: PMLiVE

AZ and Amgen are seeking approval for tezepelumab for the treatment of severe asthma patients, based on results from the companies’ PATHFINDER clinical programme. This includes data from the pivotal phase 3 NAVIGATOR trial, which demonstrated that tezepelumab achieved a […]