Drug Approval | April 18, 2022
Amneal achieves second U.S. biosimilars approval with Alymsys
Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022
Marks the second of three biosimilars Amneal expects to receive U.S. approval for in 2022
An RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications (BLA)
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
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
The valve has a saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve
Subscribe To Our Newsletter & Stay Updated
