Tag: US Food and Drug Administration

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

Granules India gets Venlafaxine ER Capsules FDA approval

businessnewstoday- May 19, 2023

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

businessnewstoday- May 13, 2023

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

businessnewstoday- May 7, 2023

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

businessnewstoday- April 30, 2023

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

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