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.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.
BioSpace4d
What Trump’s Second Term Could Mean for PDUFA’s Future
Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...
The American Journal of Managed Care3d
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 ...
Is Vertex Pharmaceuticals a Buy Now That the FDA Approved Its New Pain Drug?
Lately, one of America's leading pharmaceutical companies can't catch a break from Wall Street. Shares of Vertex ...
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 ...
Pharmaceutical Technology on MSN22h
FDA grants orphan drug status to Arbor Biotechnologies’ PH1
The FDA has granted orphan drug designation (ODD) and RPDD to Arbor Biotechnologies' ABO-101, to treat primary hyperoxaluria ...
FDA approves new type of nonopioid painkiller for acute pain
The Food and Drug Administration on Thursday approved a new type of nonopioid painkiller from Vertex Pharmaceuticals, NBC ...
Boston Herald7d
FDA approves new painkiller that shows promise and challenges of opioid alternatives
But the medication’s modest effectiveness and lengthy development process underscore ... Wall Street for its ambitious drug pipeline that involves winning FDA approval for multiple drugs across ...
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 ...
Cleveland.com7d
FDA approves new painkiller designed to avoid opioid addiction risk
But the medication’s modest effectiveness and lengthy development process underscore ... Wall Street for its ambitious drug pipeline that involves winning FDA approval for multiple drugs across ...
Verywell Health on MSN9d
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.