FDA Approvals

Under new regulations that would oversee a pandemic agreement approved by the World Health Organization, which Reuters has reviewed, pharmaceutical companies might be required...

IGBA Claims That 2022 WHO Biosimilar Guideline Boosts Access

FDA Approvals

According to the new whitepaper Embracing Science with Confidence: Adopting the Revised 2022 WHO Biosimilars Guideline from the International Generic and Biosimilar Medicines Association...

Australia Approves Faecal Transplants For Intestinal Health

FDA Approvals

Australia is the first country in the world to have awarded regulatory approval for faeces transplants. The healthy genetic material for this donation comes from...

NHS Acquires Potentially Lifesaving Breast Cancer Medication

FDA Approvals

The confidential agreement reached by the NHS and the manufacturer is expected to assist up to 1,600 women annually who have high-risk, triple-negative breast...

Food And Drug Administration User Fee Has Been Reauthorized

FDA Approvals

As anticipated, Congress swiftly reauthorized four important user fee programmes as part of a bill that was essential to passing in order to continue...

EMA Wants To Limit Immune-Regulating Medications Like FDA

FDA Approvals

On October 28th, an advisory board to the European Medicines Agency advised restricting the use of a class of medications for inflammatory diseases due...

FDA Under Strain To Amend The Accelerated Approval Program

FDA Approvals

The necessity to update and alter the FDA's now-contentious rapid approval strategy is highlighted by the protracted, complicated FDA process to discontinue commercialization of...

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