Vara Reports CE Mark Approval of its Breast Imaging AI for Independent Second Reading of Mammography

Shots:Vara has received the European CE Mark approval for its breast imaging AI to operate as an independent second reader for both screening & diagnostic use, with EU availability starting Oct 15, 2025Breast imaging AI was evaluated in the PRAIM study of 460,000 women across Germany, which demonstrated significant improvements in cancer detection &…

ByRidhi RastogiOctober 15, 2025

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Sarepta Therapeutics Reports the MHLW’s Conditional & Time-Limited Approval of Elevidys for Duchenne Muscular Dystrophy (DMD)

Shots:Japan's MHLW has granted conditional & time-limited approval to Elevidys for DMD pts (3–8yrs.) with no exon 8/9 deletions in the DMD gene & who are negative for anti-AAVrh74 AbsApproval was based on extensive clinical data, incl. 2yr. global P-III (EMBARK) trial showing motor function benefits vs external controls; Part 2 data was…

ByRidhi RastogiMay 14, 2025

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PharmaShots Interview: Guardant Health’s Justin Odegaard Shares Insight on the US FDA’s Approval of Guardant360 CDx for Amgen’s Lumakras

In an interview with PharmaShots, Justin Odegaard, Vice President of Clinical Development at Guardant Health shares his views on the Guardant360 CDx approval as the first & only liquid biopsy companion diagnostic for Amgen's Lumakras (sotorasib) KRASG12C inhibitor for use in advanced NSCLC.Shots:Guardant Health received the US FDA's approval for Guardant360 CDx liquid biopsy for use in conjunction…

BySenior EditorJuly 29, 2021

Vara Reports CE Mark Approval of its Breast Imaging AI for Independent Second Reading of Mammography

Sarepta Therapeutics Reports the MHLW’s Conditional & Time-Limited Approval of Elevidys for Duchenne Muscular Dystrophy (DMD)

PharmaShots Interview: Guardant Health’s Justin Odegaard Shares Insight on the US FDA’s Approval of Guardant360 CDx for Amgen’s Lumakras

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