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J&J joins COVID-19 booster shot drive, filing with FDA

Johnson & Johnson's COVID-19 vaccine has been a minor player in the US vaccination drive so far, but the company hopes it can have a bigger role as a booster shot.

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Enhertu nabs speedy FDA review for earlier use in breast can...

Hard on the heels of impressive new data for Enhertu as a second-line therapy for breast cancer, AstraZeneca and Daiichi Sankyo have claimed FDA breakthrough status for the drug that should

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FDA posts guidance on mining real-world data from health rec...

There is a lot of discussion about the power of drawing out insights from information hidden within electronic health records and insurance claims, but little regulatory guidance on how tha

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Closeup of X-ray photography of human brain

Biogen, Eisai double down on Alzheimer's with lecanemab fili...

Biogen and Eisai's first Alzheimer's disease drug Aduhelm is facing an uphill battle in the US market, but the partners are forging ahead with their second candidate lecanemab, starting a r

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FDA approves Pfizer COVID booster jabs for higher-risk group...

Just days after its advisory committee meeting voted to approve a third dose of Pfizer and BioNTech's COVID-19 vaccine, the FDA has followed through and cleared the shot.

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Incyte leads JAK push into eczema as FDA clears Opzelura cre...

The FDA has approved Incyte's Opzelura cream for atopic dermatitis, commonly called eczema, becoming the first and only topical JAK inhibitor registered in the US.

J&J joins COVID-19 booster shot drive, filing with FDA

Enhertu nabs speedy FDA review for earlier use in breast can...

FDA posts guidance on mining real-world data from health rec...

Biogen, Eisai double down on Alzheimer's with lecanemab fili...

FDA approves Pfizer COVID booster jabs for higher-risk group...

Incyte leads JAK push into eczema as FDA clears Opzelura cre...

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