An RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications (BLA)
This product is indicated for the short-term treatment of a breathing problem (apnea) in premature infants
An intuitive monitor featuring a patient-tailored approach is now in clinical use in select centres in U.S. and Europe
Although PCM has advanced substantially in recent years, most of the valuable technical information resides with private companies and academic publications across multiple platforms
The company plans to file its NDA in China and MAA in the EU in 2022, making Hansizhuang potentially to be the world's first PD-1 inhibitor for the first-line treatment of SCLC
If authorized by the USFDA, the Proof Lab Test System may be used to deliver accurate, actionable, lab-quality results for Covid-19 in as little as 18 minutes
Aveir VR is specifically designed to be retrieved when therapy needs to evolve or the device needs to be replaced
If approved, it will be the first USFDA-approved immunomodulator for the treatment of Covid-19 in hospitalised patients
Yescarta is First CAR T-cell therapy to receive NCCN treatment guideline category 1 recommendation --
No new studies have been requested
Subscribe To Our Newsletter & Stay Updated
