Tag: US FDA

Lupin receives FDA approval for seizures medication Diazepam Rectal Gel

businessnewstoday- June 3, 2023

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

businessnewstoday- June 1, 2023

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

businessnewstoday- May 30, 2023

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

businessnewstoday- May 30, 2023

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

businessnewstoday- May 26, 2023

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

businessnewstoday- May 25, 2023

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

businessnewstoday- May 22, 2023

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

businessnewstoday- May 21, 2023

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

businessnewstoday- May 20, 2023

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

businessnewstoday- April 30, 2023

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