J&J, GSK, Eli Lilly and others struck high-value transactions in the early days of biopharma’s annual kickoff conference.
OIG Recommends Changes in FDA Accelerated Approval After Flagging Concerns With Aduhelm, Other Drugs
The OIG recommended that the FDA define factors that would trigger an application's review by an agency council, which the agency disagreed with.
Another 109 people reported injuries after using the remote cardiac monitoring software, Modern Healthcare reported. Other pharmaceutical and tech news is on the FDA's drug approval system and a rapid ...
The pharma began submitting its TAR-200 bladder cancer treatment to the FDA. Elsewhere, Sarepta and Madrigal reported strong ...
As the year gets underway, analysts and biotech executives highlight cell therapy’s pivot from oncology to autoimmune ...
The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...
The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
By providing clearer nutrition information, the FDA hopes to empower consumers to make more informed food choices and contribute to long-term healthier eating patterns across the US.
After hours: 7:58:02 pm GMT-5 ...
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