Tag: FDA
OPPI welcomes Indian govt’s move to waive off local clinical trials...
This will be applicable to a few select drugs already approved in well-regulated markets like the USA, UK, Japan, Australia, Canada, and the EU
Moderna receives U.S. FDA approval for RSV Vaccine mRESVIA
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
Biocon Biologics obtains US-FDA approval for biosimilar Aflibercept for Yesafili
A significant milestone for the company marking its entry into ophthalmology, a new therapeutic area in the United States
Dr Reddy’s launches drug-free migraine management device Nerivio in Europe
Nerivio is approved by the United States Food and Drug Administration (USFDA), and is CE-mark certified in Europe
SynaptixBio awarded second FDA Orphan Drug Designation to boost search for...
The leading biotech company is now aiming to develop treatment for second variant of TUBB4A leukodystrophy
Qure.ai adds new FDA breakthrough device status to growing list of...
4 FDA clearances & 61 EU MDR CE tags achieved for AI in 18 months
Qure.ai’s AI-driven Chest X-Ray solution gets FDA nod for enhanced lung...
This the only FDA-cleared solution for detecting & localizing lung nodules utilizing computer vision to have Radiologists, Pulmonologists & ER physicians as intended users
FDA clears Qure.ai’s qXR-CTR chest X-ray solution as a potential indicator...
The clearance of qXR-CTR marks the company's 12th FDA-cleared algorithm, solidifying its position as an industry leader
Qure.ai receives 510(k) FDA clearance for its Chest X-ray solution for...
qXR has shown exemplary clinical accuracy in triaging pneumothorax (PTX), a condition where air collects in the pleural space, causing the lung to collapse
CPHI annual report predicts AI to transform all processes in drug...
In 2030 over 50% of FDA approvals will involve AI discovered and developed drugs