Please login to the form below

Not currently logged in
Email:
Password:

FDA extends review period for ipilimumab

The US FDA has determined that additional time is required to complete the review of the biologics licence application for BMS' ipilimumab

Bristol-Myers Squibb (BMS) has announced that the US Food and Drug Administration (FDA) has determined that additional time is required to complete the review of the biologics licence application (BLA) for ipilimumab, which is used for pre-treated advanced melanoma.

The decision date has been moved from December 25, 2010 to March 26, 2011.

In response to an FDA request, BMS submitted further analysis of data pertaining to the current application for pre-treated advanced melanoma, and FDA considers this to be a major amendment to the drug's BLA.

BMS has said that it continues to be very encouraged by its interactions with the FDA and remains confident in the overall development programme for ipilimumab.

Ipilimumab is also currently under review with the European Medicines Agency (EMA) and other health authorities worldwide for pre-treated advanced melanoma.

3rd November 2010

Share

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
bmore group

OUR PROMISE: BETTER HEALTH FROM TRIAL TO TREATMENT.We are a full service, independent network of specialist agencies under one roof....

Latest intelligence

New from the PhRMA: Diversity in clinical trials principles summarised
In November 2020, PhRMA announced the first-ever, industry-wide principles on clinical trial diversity. The principles were approved by the PhRMA Boards of Directors and will take effect in April 2021....
New from the FDA: Diversity in clinical trials guidance summarised
In November 2020, the FDA released guidance to enable greater diversity in clinical trials through changes to eligibility criteria, enrolment practices, and trial designs....
5 steps to effective clinical trial branding
When recruiting patients for your clinical trial, you want the materials and information around it to be seen as reputable and professional. To make it clear what the clinical trial...

Infographics