Tag: US Food and Drug Administration
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
Granules India gets Venlafaxine ER Capsules FDA approval
Granules India has secured approval for its abbreviated new drug application (ANDA) for Venlafaxine Hydrochloride Extended-Release (ER) Capsules USP, 37.5 mg, 75 mg, and 150 ... Read More
FDA committee backs approval of Sarepta Therapeutics’ SRP-9001 for DMD
Sarepta Therapeutics’ SRP-9001 (delandistrogene moxeparvovec) has received the backing of the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC) of the US Food and Drug ... Read More
Zydus Lifesciences gets FDA final approval for Sucralfate Tablets
Zydus Lifesciences has bagged final approval to manufacture and market Sucralfate Tablets USP, 1 gram from the US Food and Drug Administration (FDA). The approved ... Read More
EarlyTect BCD test : Promis Diagnostics gets FDA breakthrough designation
Promis Diagnostics has secured breakthrough device designation for its non-invasive EarlyTect BCD test from the US Food and Drug Administration (FDA) as a urine-based diagnosis ... 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
