Browsing Tag
US Food and Drug Administration
348 posts
FDA approves Cardio Flow Design’s iTFlow for enhanced cardiovascular diagnosis
The US Food and Drug Administration (FDA) has granted approval for iTFlow, a software solution developed by Cardio…
Zydus Lifesciences gets FDA final approval for Varenicline Tablets
Zydus Lifesciences has been granted final approval from the US Food and Drug Administration (FDA) to manufacture and…
Zydus Lifesciences’ Diclofenac Sodium and Misoprostol Tablets gets FDA final approval
Zydus Lifesciences has secured final approval from the US Food and Drug Administration (FDA) to manufacture and market…
Granules India gets FDA approval for generic epilepsy drug Levetiracetam
Granules India has announced its receipt of approval from the US Food and Drug Administration (FDA) for its…
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…
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…