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 ...
federalnewsnetwork.com6d
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 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 ...
What Is Journavx? First Pain Medication Approved by FDA in Over Two Decades
This milestone marks a breakthrough after unsuccessful attempts to develop painkillers without the addictive potential of ...
R Street Institute5dOpinion
Trump: Look at the Slow-Moving FDA
The Food and Drug Administration’s approval of low-risk tobacco pouches is welcome, but why did it delay for more than four ...
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 MSN7d
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.
LAist10d
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 ...
FDA approves new type of nonopioid painkiller for acute pain
The drug, Journavx, from Vertex Pharmaceuticals, reduced pain after surgery in clinical trials. Experts hope it can lead to fewer opioid prescriptions.
FDA spars with Waco company over ‘unapproved’ and ‘unlicensed’ human amniotic products
Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that ...
CNN7d
FDA approves Ozempic to reduce risks from chronic kidney disease in diabetes patients
The new indications, approved Tuesday by the FDA, make Ozempic the most broadly indicated drug in its class ... clinicians with their decision-making process, and it helps them focus those ...
NPR11d
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 ...