Biocartis Group NV received premarket approval from the U.S. FDA for its Idylla Cdx MSI test, developed in partnership with Bristol Myers Squibb Co., to help in the diagnosis and treatment of colorectal cancer. The cartridge-based, fully automated, sample-to-result test enables faster identification of patients with the disease who may benefit from therapeutic treatment.
“The comment I hear a lot from scientists … is that science has no borders,” Arif Noorani, partner at Sidley Austin LLP, said while addressing the panel audience at Asia Bio 2025 in Singapore. “I agree, but the reality is, we do have a lot of borders.”
Recent comments from CDER Director George Tidmarsh suggesting that the agency may be backing away from the use of its independent expert panels for individual product approvals seem to be supported by the numbers.
It took a memo from the president for the U.S. FDA to begin reining in direct-to-consumer prescription drug advertising with its feel-good messaging and hurried recitation of a few serious adverse events.
When it won U.S. FDA accelerated approval more than eight years ago, Intercept Pharmaceuticals Inc.’s Ocaliva (obeticholic acid) was viewed as a breakthrough, becoming the first new treatment in 20 years for rare, progressive liver disease primary biliary cholangitis (PBC) and, for several years, the only second-line treatment for PBC patients failing to respond to ursodeoxycholic acid. More recently, however, Ocaliva has faced regulatory and safety stumbles, with Intercept now voluntarily pulling the farnesoid X receptor activator from the U.S. market.
The U.S. FDA issued new guidance for the development of non-opioid analgesics for chronic pain indications, with specific details on trial design, patient populations and meaningful outcomes, including reducing the nation’s reliance on opioids.
“The comment I hear a lot from scientists … is that science has no borders,” Arif Noorani, partner at Sidley Austin LLP, said while addressing the panel audience at Asia Bio 2025 in Singapore. “I agree, but the reality is, we do have a lot of borders.”
It took a memo from the president for the U.S. FDA to begin reining in direct-to-consumer prescription drug advertising with its feel-good messaging and hurried recitation of a few serious adverse events.
Less than two months after receiving priority review status for an NDA, Johnson & Johnson won U.S. FDA approval of Inlexzo, its intravesical gemcitabine-releasing system previously known as TAR-200, to treat adults with Bacillus Calmette-Guérin-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors.
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