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
This product will be manufactured at Lupin’s Nagpur facility in India
The product will be manufactured at Lupin’s facility in Goa, India
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
Subscribe To Our Newsletter & Stay Updated
