Browsing Tag
US Food and Drug Administration
333 posts
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…
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…
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…
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…
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…
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…
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…
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…
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…
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…