Lupin clinches FDA approval for generic Spiriva HandiHaler
Indian pharma titan Lupin has announced receiving approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Tiotropium Bromide ... Read More
Zydus Lifesciences bags FDA final approval for generic of acne medication
Zydus Lifesciences has received the final approval from the US Food and Drug Administration (FDA) for Minocycline Hydrochloride Extended-Release Tablets in 55 mg, 65 mg, ... Read More
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 Flow Design Inc. (Japan), that improves the ... Read More
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 Diclofenac Sodium and Misoprostol Delayed Release Tablets ... Read More
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 Abbreviated New Drug Application (ANDA) for Levetiracetam ... Read More
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 abbreviated new drug application (ANDA) for Tipiracil ... Read More
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) for the treatment of cholestatic pruritus in ... Read More
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 the US Food and Drug Administration (FDA) ... Read More
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 from the US Food and Drug Administration ... Read More
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 abbreviated new drug application (ANDA) for Obeticholic ... Read More