The review, which was spurred by controversy over the FDA's Aduhelm approval, recommends two main changes in agency ...
Ozempic, the blockbuster GLP-1 drug that was originally approved to treat type 2 diabetes, has now also been approved by the ...
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 ...
Verywell Health on MSN10h
Spravato Nasal Spray Can Now Be Used Alone for Treatment-Resistant DepressionPeople with treatment-resistant depression can now take Spravato's ketamine-derived nasal spray as a standalone treatment.
The FDA granted fast track designation to 64Cu-SAR-bisPSMA for PET imaging of PSMA-positive prostate cancer lesions in ...
The FDA fast-tracked Spravato’s approval through its Priority Review process after receiving results from a randomized, double-blind, placebo-controlled study of the medication. Volunteers were ...
The Food and Drug Administration (FDA) has recently released two draft guidance documents (Artificial Intelligence-Enabled Device Software ...
The Associated Press on MSN13d
Newsom committed California to making its own insulin. It’s at least a year behind his schedule“That process is underway and moving forward ... and all parties continue to advance development toward FDA approval with ...
Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a novel treatment to treat autism spectrum ...
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