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 ...
Federal News Network13d
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.
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 ...
Superbowl Ad Sparks A Healthy Controversy About Medication Safety
The next FDA Commissioner could solve two big problems with one powerful policy: encourage independent testing of both ...
American Council on Science and Health22h
Rare Diseases Are Neglected. The FDA Needs A Dedicated 'Center of Excellence for Rare Diseases'.
The FDA has made some modest efforts, but it needs an internal organization that understands and would be an aggressive ...
The Associated Press on MSN12d
FDA approves new painkiller that shows promise and challenges of opioid alternatives
The U.S. Food and Drug Administration said it approved Vertex Pharmaceuticals’ Journavx for short-term pain that often ...
The American Journal of Managed Care8d
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 ...
NBC News on MSN11d
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.
The American Journal of Managed Care4d
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 ...
CBS News11d
FDA OK's painkiller designed to end opioids' addiction and overdose risk
The U.S. Food and Drug Administration said it approved Vertex Pharmaceuticals ... medication's modest effectiveness and lengthy development process underscore the challenges of finding new ...
The Motley Fool10d
Is Vertex Pharmaceuticals a Buy Now That the FDA Approved Its New Pain Drug?
The U.S. Food and Drug Administration approved a new prescription-strength ... centers in the U.S. had initiated the treatment process with over 50 patients. In December, the FDA approved Alyftrek ...