Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...
The American Spectator9d
Trump: Look at the Slow-Moving FDA
However, the agency’s inexplicable delay in doing so raises serious questions about the FDA’s bureaucratic and unaccountable ...
federalnewsnetwork.com8d
FDA’s accelerated approval pathway has a few potholes
The Health and Human Services Office of Inspector General has found that, in a few cases, FDA officials veered from the accelerated approval pathway.
The American Journal of Managed Care4d
OIG Report Seeks Better Oversight, Records for FDA’s Accelerated Approvals
Amid the uproar over the firing of 18 inspectors general, a report offering a coda to the aducanumab approval episode has ...
The American Journal of Managed Care2h
Evolent’s Wonsettler Sees Outcomes-Based Reimbursement as “A Healthy Tool”
Terra Wonsettler, PharmD, MBA, vice president of pharmacy for Evolent, discusses the recent HHS OIG report that stemmed from ...
With FDA approval, Genentech turns eye implant's focus to diabetes
Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...
Verywell Health on MSN10d
Spravato Nasal Spray Can Now Be Used Alone for Treatment-Resistant Depression
People with treatment-resistant depression can now take Spravato's ketamine-derived nasal spray as a standalone treatment.
Cleveland.com7d
FDA approves new painkiller designed to avoid opioid addiction risk
The U.S. Food and Drug Administration said it approved Vertex Pharmaceuticals ... s modest effectiveness and lengthy development process underscore the challenges of finding new ways to manage ...
NPR13d
The FDA pulls key DEI initiative for cancer studies from its website
That gave the FDA a way to communicate expectations to drugmakers about how clinical trials should be conducted to support a drug approval ... There is a formal process for removing guidance ...
AOL5d
Is Vertex Pharmaceuticals a Buy Now That the FDA Approved Its New Pain Drug?
At the end of 2024, more than 50 authorized treatment centers in the U.S. had initiated the treatment process with over 50 patients. In December, the FDA approved Alyftrek, a new once-daily pill ...
LAist12d
The FDA pulls key DEI initiative for cancer studies from its website
A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...