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Input on Biosimilar Product Development Guidance Documents Sought by FDA

The questions come as FDA is revisiting best practices for advancing the development of new biosimilar products under the terms of its updated Biosimilars Action Pla...

29 July 2024 news Biosimilar | FDA

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Adaptimmune Gears Up for Potential Approval of First-in-Class Engineered T Cell Therapy

After more than a decade devoid of therapeutic advancements, a first-in-class T cell receptor therapy could be on the immediate horizon for synovial sarcoma patients...

29 July 2024 news cancer | FDA

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FDA clears Galaxy robotic surgery system, sending lung cancer diagnosis to a new frontier

A surgical robot system developed by Noah Medical and newly cleared by the FDA is out of this world—or, at least, the current world of bronchoscopy procedures. Bronc...

6 March 2023 news diagnose lung cancer | FDA

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With spotlight on FDA, Congress weighs reforms to accelerated drug approvals

Over the past few years, the Food and Drug Administration has come increasingly under scrutiny for its program to grant speedy approvals to drugs that show early sign...

13 May 2022 news approvals | Congress

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FDA places stricter limits on J&J’s COVID-19 vaccine after review of rare side effect

Dive Brief: The Food and Drug Administration has determined that the risk of a rare, but serious, clotting syndrome tied to Johnson & Johnson’s COVID-19 vaccin...

9 May 2022 news COVID-19 | FDA

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FDA sets back Novartis’ best chance at a COVID-19 drug

Dive Brief: Novartis is reevaluating its commitment to an experimental COVID-19 treatment originally developed by fellow Swiss drug company Molecular Partners afte...

28 April 2022 news Amgen | COVID-19

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FDA panel supports agency push to raise approval bar for certain cancer drugs

The Food and Drug Administration appears ready to raise its approval standards for a well-known class of cancer drugs due to concerns they aren't helping patients liv...

25 April 2022 news blood | cancer

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FDA clears Gilead to restart some studies of top cancer drug

Dive Brief: The Food and Drug Administration has cleared Gilead to restart some trials testing an experimental cancer drug the company acquired in a roughly $5 bil...

14 April 2022 news cancer | Drug

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FDA advisers grapple with how to update COVID-19 vaccines

A group of advisers to the Food and Drug Administration agreed Wednesday that COVID-19 vaccines will likely need to be updated to keep pace with a fast-changing coron...

11 April 2022 news COVID-19 | dose

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Akebia to lay off 42% of workforce, suspend trials after FDA drug rejection

Dive Brief: Akebia Therapeutics will lay off 42% of its workforce after the Food and Drug Administration last month rejected its most advanced experimental drug, a...

11 April 2022 news Akebia | Drug

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Input on Biosimilar Product Development Guidance Documents Sought by FDA

Adaptimmune Gears Up for Potential Approval of First-in-Class Engineered T Cell Therapy

FDA clears Galaxy robotic surgery system, sending lung cancer diagnosis to a new frontier

With spotlight on FDA, Congress weighs reforms to accelerated drug approvals

FDA places stricter limits on J&J’s COVID-19 vaccine after review of rare side effect

FDA sets back Novartis’ best chance at a COVID-19 drug

FDA panel supports agency push to raise approval bar for certain cancer drugs

FDA clears Gilead to restart some studies of top cancer drug

FDA advisers grapple with how to update COVID-19 vaccines

Akebia to lay off 42% of workforce, suspend trials after FDA drug rejection

International Biopharmaceutical Industry