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 Journal of Managed Care2d
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 Spectator7d
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.com7d
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.
Newsweek6d
What Is Journavx? First Pain Medication Approved by FDA in Over Two Decades
The FDA's approval process for Journavx included an evaluation of its safety and efficacy. Clinical trials demonstrated that the drug is effective in managing acute pain without the adverse ...
FDA approves painkiller designed to eliminate the risk of addiction associated with opioids
Federal officials on Thursday approved a new type of pain pill designed to eliminate the risks of addiction and overdose ...
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 ...
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 MSN8d
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.
AOL4d
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 ...