regulatory

News

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.

News

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.

News

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.

News

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.

Market Access

weight loss injections and measuring tape

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

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

News

FDA delays decision on Sanofi's subcutaneous Sarclisa

The FDA has extended its review of a new version of Sanofi's multiple myeloma Sarclisa that could help narrow the gap with arch-rival Darzalex.

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

FDA delays decision on Sanofi's subcutaneous Sarclisa

Infex chases after Insmed with bronchiectasis trial win

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

regulatory

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