Browsing Tag
US Food and Drug Administration
333 posts
Zydus Lifesciences’ Ahmedabad plant passes FDA inspection with no observations
AHMEDABAD, INDIA – Indian lifesciences company, Zydus Lifesciences, announced on Tuesday that its injectables manufacturing facility at Zydus…
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)…
FDA greenlights Granules India’s Metoprolol Succinate ER tablets
Granules India Limited announced its receipt of US Food and Drug Administration (FDA) approval for its Abbreviated New…
Caplin Point to tap into $35m market after FDA approval for NIMBEX generic
Caplin Steriles, a subsidiary of India’s Caplin Point Laboratories, has obtained final approval from the US Food and…
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…