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FDA accepts Mesoblast’s latest BLA for paediatric GvHD cell therapy
Pharmaceutical Technology· 11 hours agoMesoblast has announced that the US Food and Drug Administration (FDA) has accepted a resubmitted...
Zydus Lifesciences wins FDA nod for Valsartan Tablets | India Infoline
India Infoline· 3 hours agoZydus Lifesciences Ltd has obtained final approval from the United States Food and Drug Administration (FDA) for Valsartan Tablets, which are used to treat ...
FDA approves Samsung Bioepis’ EPYSQLI as Soliris biosimilar
Pharmaceutical Technology· 21 hours agoSamsung Bioepis has announced the approval of its EPYSQLI (eculizumab-aagh) biologics licence...
US FDA inspection of Zydus Lifesciences ends with 2 observations - CNBC TV18
CNBC TV18· 5 days agoUS Food and Drug Administration (FDA) has inspected the group’s transdermal manufacturing site...
FDA issues 510(k) clearance for new functionality of Varian’s Ethos system
Medical Device Network· 23 hours agoThe US Food and Drug Administration (FDA) has issued 510(k) clearance to the new functionality for...
Jaguar Health shares slump following Phase III Mytesi failure
Clinical Trials Arena· 15 hours agoShares in the Nasdaq-listed company opened 66% lower compared to a pre-announcement market close....
Enhertu set to become a blockbuster drug after outperforming Kadcyla
Clinical Trials Arena· 2 days agoA collaboration with AstraZeneca for the drug's further development and commercialisation was...
FDA Pune Cracks Down on 112 Medical Stores, Suspends and Cancels Multiple Licenses
Free Press Journal· 2 days agoThe Food and Drug Administration (FDA), Pune, took action against 112 retail medical stores across...
Spryte’s nOCT technology secures breakthrough device designation
Medical Device Network· 23 hours agoSpryte Medical has secured breakthrough device designation from the US Food and Drug Administration...
FDA launches new rare disease innovation hub
Pharmaceutical Technology· 6 days agoA new rare disease innovation hub set up by the US Food and Drug Administration (FDA) aims to expedite the development and approval of orphan drugs. Rare...
