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Browsing Tag
US FDA
US FDA expands deployment of Waters Corporation Software to support its medical products testing…
Transition to electronic records management system will speed data retrieval, automate essential audit and archival functions, and…
US limits use of Regeneron and Eli Lilly COVID-19 antibody treatments amid Omicron spread
The Food and Drug Administration (FDA) said the treatments are currently not cleared for use in any US states or territories, but…
US FDA amends J&J vaccine fact sheet to include rare bleeding risk
The amendment fact sheet follows similar moves for the vaccine by other regulators, including that of the European Medicines…
AbbVie submits applications for Upadacitinib in to US FDA and EMA
In the trial study, evaluating the efficacy and safety of Upadacitinib in adult patients with nr-axSpA, Upadacitinib met its…
Interval between Moderna COVID-19 vaccine second shot and booster still six months: FDA
"Right now, if you got J&J, you get a booster after two months, if you got Pfizer as your primary series you can get a booster…
Novavax submits final data to US FDA as prerequisite to EUA application request for COVID-19 vaccine
Novavax has filed the complete CMC data package, which leverages Novavax's manufacturing partnership with the Serum Institute of…
Zydus receives Orphan Drug Designation from US FDA for malaria treatment
The Orphan Drug Designation provides up to seven years of marketing exclusivity in the US
Lupin’s Goa manufacturing plant gets EIR from US FDA
FDA changes inspection classification of the facility to Voluntary Action Indicated (VAI)
Lupin recalls 4,113 cartons of oral contraceptive medicine in US market
The affected lot has been produced at the company’s Pithampur-based manufacturing facility in Madhya Pradesh and distributed in…