Tag: US FDA
Lupin receives FDA approval for seizures medication Diazepam Rectal Gel
Lupin announced that its subsidiary Novel Laboratories has received approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application for ... Read More
Caplin Point Laboratories’ sterile injectable site completes FDA inspection
Caplin Point Laboratories, an Indian pharmaceutical company, has announced that the US Food and Drug Administration (FDA) has concluded its Good Manufacturing Practices (GMP) and ... Read More
GE HealthCare’s Precision DL bags FDA clearance to revolutionize PET/CT performance
GE HealthCare has announced the US Food and Drug Administration (FDA) 510(k) clearance of Precision DL, a deep learning-based image processing software. This new addition ... Read More
Concept Medical gets FDA IDE approval for MagicTouch PTA for Superficial Femoral Arteries
Concept Medical has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) for its Sirolimus Coated Balloon (SCB) MagicTouch PTA ... Read More
Pulse Medical μFR system gets FDA breakthrough status for pan-vascular diagnosis
Pulse Medical Technology has announced that its fourth-generation μFR system has received breakthrough device designation from the US Food and Drug Administration (FDA) for pan-vascular ... Read More
Pfizer gets PAXLOVID FDA approval for COVID-19 in high-risk adults
Pfizer has obtained approval for PAXLOVID, an oral combination therapy of nirmatrelvir tablets and ritonavir tablets, from the US Food and Drug Administration (FDA) to ... Read More
Hanx Biopharmaceuticals set to begin US clinical trial of HX009 in lymphoma
Hanx Biopharmaceuticals (HanxBio) has obtained approval from the US Food and Drug Administration (FDA) for its investigational new drug (IND) of HX009, enabling the company ... Read More
Genmab gets EPKINLY FDA approval for diffuse large B-cell lymphoma
Danish biotech company Genmab has secured accelerated approval for EPKINLY (epcoritamab-bysp) from the US Food and Drug Administration (FDA) for the treatment of relapsed or ... Read More
Reflow Medical gets FDA commercial clearance for coraCatheters
Reflow Medical has obtained commercial clearance from the US Food and Drug Administration (FDA) for its coraCatheters range of microcatheters. These specialized devices are designed ... Read More
Teva Pharmaceuticals, MedinCell get UZEDY FDA approval for schizophrenia
Teva Pharmaceuticals and MedinCell have bagged approval for UZEDY (risperidone) extended-release injectable suspension from the US Food and Drug Administration (FDA) for schizophrenia treatment in ... Read More
