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Eisai, Biogen face delay to subcutaneous Leqembi

Eisai and Biogen are facing a delay in the FDA review of injectable Leqembi for initial dosing in Alzheimer's, viewed as a key growth driver.

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FDA's ODAC delivers one loss, one win for AstraZeneca

The FDA's cancer drugs committee backs AstraZeneca's Truqap in prostate cancer, but is unmoved by data for breast cancer candidate camizestrant.

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Amgen, AZ will pilot FDA's real-time clinical trial plan

The FDA has published a plan to allow data from clinical trials to be reported to the agency as they occur in real time.

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GSK eyes October FDA verdict on chronic hep B drug

GSK's antisense-based drug for chronic hepatitis B (CHB), bepirovirsen, has started a speedy FDA review that should deliver a verdict by 26th October.

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FDA declines to approve AbbVie's Botox follow-up

AbbVie's bid to bring a rapid and shorter-acting botulinum toxin product to the US market has been knocked back by the FDA.

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Counterfeit drug promotion is a patient safety, brand equity, and public trust issue.

Eisai, Biogen face delay to subcutaneous Leqembi

FDA's ODAC delivers one loss, one win for AstraZeneca

Amgen, AZ will pilot FDA's real-time clinical trial plan

GSK eyes October FDA verdict on chronic hep B drug

FDA declines to approve AbbVie's Botox follow-up

Fighting fake GLP-1s to protect patients & preserve trust

Lily gets FDA nod for SERD-CDK 4/6 combo in breast cancer

Discover a new era of healthcare panel engagement: Grounded ...

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