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Xtandi cleared by FDA for earlier-stage prostate cancer

Already a mainstay of prostate cancer therapy, Pfizer and Astellas’ Xtandi has picked up a new approval in the US that could reinvigorate the drug, even as it approaches i

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FDA’s Janet Woodcock will step down early next year

Janet Woodcock will bring a career at the FDA spanning almost four decades to a close next year, retiring from her current role as principal deputy commissioner of the reg

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AZ first to AKT finish line, but FDA clears narrow label

AstraZeneca has claimed FDA approval for its first-in-class pan-AKT inhibitor capivasertib, getting a green light for the drug as a treatment for breast cancer, but with a

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FTC challenges dozens of ‘improper’ US drug patents

The financial regulator in the US has sent letters to 10 companies that it claims have improperly listed patents in the FDA’s ‘Orange Book’ in order to block generic rival

Market Access

DSCSA & dispensers: In the relay race of compliance, how to ...

Leading up to the end of August, I was looking forward to attending the HDA Traceability Seminar in Washington, DC.

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FDA will add digital health advisory committee to its roster

The FDA is setting up a new advisory committee to provide independent expertise on the emerging category of technologies like digital therapeutics, virtual and augmented r

Xtandi cleared by FDA for earlier-stage prostate cancer

FDA’s Janet Woodcock will step down early next year

AZ first to AKT finish line, but FDA clears narrow label

FTC challenges dozens of ‘improper’ US drug patents

DSCSA & dispensers: In the relay race of compliance, how to ...

FDA will add digital health advisory committee to its roster

GBL joins CVC in €10.7bn takeover bid for Recordati

Discover a new era of healthcare panel engagement: Grounded ...

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