Browsing Tag
US Food and Drug Administration
348 posts
Lupin obtains FDA approval for generic version of Ocaliva Tablets
Indian pharmaceutical company Lupin has announced its approval from the US Food and Drug Administration (FDA) for its…
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)…
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…
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…
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…
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…