Tag: FDA
US FDA import alert on Dabur plant
The US Food and Drug Administration (FDA) has issued an Import Alert (IA 66-40) for drugs manufactured at a section of Dabur India’s plant...
Aurobindo Pharma Telangana facility gets OAI classification from FDA
The US Food and Drug Administration (FDA) has classified Unit-I of Aurobindo Pharma’s wholly owned subsidiary, Eugia Pharma Specialities, as 'Official Action Indicated' (OAI)...
FDA clears Philips AI solution
Royal Philips, a global leader in health technology, has received US Food and Drug Administration (FDA) 510(k) clearance for the EchoNavigator R5.0 with DeviceGuide,...
FDA approves Novo Nordisk’s Sogroya
Novo Nordisk has announced that the US Food and Drug Administration (FDA) has approved three new indications for once-weekly Sogroya (somapacitan-beco) injection 5 mg,...
Three ways pharma manufacturers can accelerate time-to-market of new products
Pharmaceutical production is recognized as an important benefit for our modern lives. According to IQVIA Institute for Human Data Science, total spending and global...
FDA clears new blood test for Alzheimer’s
With Alzheimer’s rates climbing and diagnoses often delayed until symptoms progress, a new FDA-cleared blood test could mark a turning point in how the...
FDA grants approval of SQ Innovation’s Lasix ONYU
Gerresheimer, an innovative system and solution provider and a global partner for the pharma, biotech and cosmetics industries, announces that the US Food and...
Biocon Biologics gets FDA nod for Bosaya & Aukelso Denosumab Biosimilars
Biocon Biologics, a fully integrated global biosimilars company and subsidiary of Biocon, has announced that the US Food and Drug Administration (FDA) has approved...
PharmNovo gets positive FDA feedback for neuropathic pain pain
PharmNovo, a Swedish clinical-stage pharmaceutical company focused on developing safe and effective drugs for neuropathic pain, has announced that it has received positive and...
FDA approval for Aptar CSP N-sorb solution
Aptar CSP Technologies a long time AIPIA member, part of AptarGroup and a leader in active material science, has announced that its N-Sorb nitrosamine...