Bristol-Myers Squibb has withdrawn its EU application to extend Opdivo’s use to metastatic colorectal cancer (mCRC), following a similar move for liver cancer last year. But the mCRC withdrawal is likely to have limited commercial impact and the company is more interested in pursuing the product’s use in combination treatment for this indication.
Bristol-Myers Squibb Co.’s decision to pull its EU application to use its PD-1 inhibitor Opdivo (nivolumab) in the additional indication of metastatic colorectal cancer (mCRC) follows a similar withdrawal for the drug in liver cancer last year.
This is something of a regulatory setback for BMS, but in commercial terms the latest withdrawal is unlikely to have...
The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.
Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.
UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.
The US FDA approved taletrectinib for the treatment of ROS1+ NSCLC, where Nuvation hopes it will lead the category with a best-in-class position.
Lilly’s Mounjaro for diabetes rose from sixth to third position among the top-selling drugs in the first quarter of 2025, Rival Ozempic retained second position and Merck & Co’s immuno-oncology blockbuster Keytruda stayed far ahead.
Oral RNA splicing modulator has gone into a Phase II/III trial
Highlights from Day 3 of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.
