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Will Gottlieb follow up on Trump's promise of a bonfire of regulations?

Biden appoints veteran Woodcock as interim FDA commissioner

Agency veteran Dr Janet Woodcock is the new interim FDA commissioner appointed by president Joe Biden to replace outgoing Trump appointee Stephen Hahn.

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US eyes permanent change to digital health regulatory path

Developers of digital health tools have benefited from a truncated route to market during the COVID-19 crisis, and that could be made permanent if new FDA guidance is adopted.

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Boehringer, Lilly’s Jardiance tries to match AZ’s Farxiga wi...

Boehringer and Eli Lilly have moved closer to a heart failure indication for their SGLT2 inhibitor Jardiance, as the FDA starts a fast-track review of the drug in its first use beyond diabe

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FDA and doctors warn against extending COVID-19 vaccine dose...

Tinkering with the dosing schedule of COVID-19 vaccines runs a “significant risk” to public health, the FDA has warned in a statement after the UK announced plans to prioritise the first do

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FDA rejects Novartis' cholesterol drug after factory inspect...

Novartis’ cholesterol drug inclisiran has hit a speed bump with the FDA, which has rejected the potential blockbuster because a manufacturing facility has yet to be inspected.

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Glass Medicine Vials and botox, hualuronic, collagen or flu Syringe on a white background.

Moderna’s COVID-19 vaccine is second for US after FDA green ...

As expected, the FDA has moved swiftly ahead with emergency approval of Moderna’s COVID-19 vaccine after a positive assessment at its vaccines advisory committee.

Biden appoints veteran Woodcock as interim FDA commissioner

US eyes permanent change to digital health regulatory path

Boehringer, Lilly’s Jardiance tries to match AZ’s Farxiga wi...

FDA and doctors warn against extending COVID-19 vaccine dose...

FDA rejects Novartis' cholesterol drug after factory inspect...

Moderna’s COVID-19 vaccine is second for US after FDA green ...

Neurocrine pays $2.9bn for Soleno and extreme hunger drug

Using AI-driven synthetic personas to take your insights fur...

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