AstraZeneca & Amgen Seek EU Fast-Track For Severe Asthma Drug
Tezepelumab was among four products that the European Medicines Agency most recently considered for review under its accelerated assessment mechanism.
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One out of seven requests for the accelerated assessment of planned EU marketing authorization applications is known to have been granted this year to date.
Data presented at AAAI meeting show reduced annualized asthma exacerbation rates across all patient populations, but doctors are unlikely to switch patients served well by existing biologics.
The company paid twice Immunomedics’ last closing stock price to access Trodelvy, approved for triple-negative breast cancer with potential in other solid tumors as monotherapy and in combinations.