Biopharma Business

Tag "US Food and Drug Administration"

FDA collaboration uses Organs-on-Chips to improve drug development

    FDA collaboration uses Organs-on-Chips to improve drug development

CN Bio Innovations Limited has announced today that it has entered into a Research Collaboration Agreement with the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research

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FDA approves Bydureon BCise for patients with type-2 diabetes

    FDA approves Bydureon BCise for patients with type-2 diabetes

The FDA has approved Bydureon BCise for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines. AstraZeneca has announced that the US Food and Drug Administration

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US approves second CAR-T therapy

    US approves second CAR-T therapy

Gilead’s Yescarta – recently acquired through its purchase of Kite Pharma -has become the second gene therapy to be approved by the US Food and Drug Administration, offering a new

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Cork-based AventaMed eyes FDA approval after raising €1.8m

    Cork-based AventaMed eyes FDA approval after raising €1.8m

AventaMed, a Cork-based medtech firm focused on simplifying surgical procedures, has secured a €1.8 million investment to enable the company to attain FDA approval and go to market in the

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FDA accepts regulatory submission for Lynparza in metastatic breast cancer

    FDA accepts regulatory submission for Lynparza in metastatic breast cancer

Lynparza has the potential to offer a new treatment option for patients with metastatic breast cancer. AstraZeneca and Merck & Co., have announced that the US Food and Drug Administration

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Janssen announces FDA approval of Stelara for plaque psoriasis

    Janssen announces FDA approval of Stelara for plaque psoriasis

The FDA has approved an expanded indication for Stelara for the treatment of adolescents with moderate plaque psoriasis. Janssen Biotech, Inc., has announced that the U.S. Food and Drug Administration

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FDA Acts to Eencourage Generic Competition for Complex Drugs

    FDA Acts to Eencourage Generic Competition for Complex Drugs

The U.S. Food and Drug Administration is opening a new front in its efforts to reduce high drug prices by encouraging development of generic versions of hard-to-make medicines. Complex drugs

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FDA approves Abbott’s molecular Zika virus test

The US Food and Drug Administration (FDA) has authorised Abbott’s molecular test to detect Zika virus in whole blood (when collected alongside a patient-matched serum or plasma sample) for emergency

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