Browsing Tag
US FDA
379 posts
Natco Pharma wins FDA approval for generic colorectal cancer drug
Indian pharmaceutical firm Natco Pharma has gained the US Food and Drug Administration (FDA)’s final approval for its…
Ipsen gets Bylvay FDA approval for cholestatic pruritus in Alagille syndrome
The US Food and Drug Administration (FDA) has granted approval to French biopharmaceutical company Ipsen for Bylvay (odevixibat)…
Zydus Lifesciences gets FDA final approval for Balsalazide Disodium Capsules
Zydus Lifesciences, along with its subsidiaries and affiliates, has achieved a significant milestone with the final approval from…
AVATAR MEDICAL virtual reality surgical planning solution gets FDA clearance
French medtech startup AVATAR MEDICAL announced that its virtual reality (VR) surgical planning solution has received 510(k) clearance…
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…