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SS Innovations Seeks De Novo on Surgical Robot

[ Price : $8.95]

SS Innovations says it will seek a de novo marketing authorization in July for its SSi Mantra 3 surgical robotic system.

FDA Misses GSK Nucala for COPD Review Decision

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FDA again misses a user fee review action decision in the wake of mass staff cuts, the third miss in a month this time it's a GSK...

Odds Low for DTC Ad Ban: Conference Speakers

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Speakers at the DTC National conference suggest a ban on drug DTC ads is not very likely.

Gottlieb, McClellan Hit FDA Reorganization Plan

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Former FDA commissioners Scott Gottlieb and Mark McClellan voice concerns about an HHS proposed reorganization of FDA that would c...

Michael Rogers Resigns from FDA

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CBS News reports that FDA associate commissioner for inspections and investigations Michael Rogers is retiring, frustrated over ch...

FDA Picks Booz Allens Walsh as AI Chief

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FDA taps former Booz Allen Hamilton chief technologist Jeremy Walsh to lead its artificial intelligence (AI) and information techn...

Teva/Alvotechs Interchangeable Stelara Biosimilar OKd

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FDA approves Teva Pharmaceuticals and Alvotechs Selarsdi injection as an interchangeable biosimilar to Janssens reference biologic...

Inspection Disruptions Wont Rise to Covid Level: Expert

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Former CDER Office of Compliance director Don Ashley says inspection disruptions caused by recent FDA reductions in force will not...

Therivas Pancreatic Cancer Drug Hits Endpoints

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Theriva Biologics reports positive Phase 2b VIRAGE topline results for its VCN-01 when added to standard of care chemotherapy to t...

Moderna Flu/Covid Vaccine Beats Comparators: Study

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A Moderna Phase 3 study says its combination mRNA flu and Covid-19 vaccine achieved a greater immune response than comparator stan...