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 ...
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 ...
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 ...
Journey Medical: FDA Approval For Emrosi Makes This An Exciting Stock
The approval Journey Medical received from FDA for Emrosi makes DERM an exciting stock. Click here to read more.
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 ...
FDA approves painkiller designed to eliminate the risk of addiction associated with opioids
The FDA approved a pain drug designed to eliminate the risks associated with opioids -- the first new pharmaceutical approach ...
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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 ...
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Biocurious: EBR Systems is on a ‘glide path’ to FDA approval for its novel heart device
EBR Systems is super confident the US medical gatekeeper will approve Wise, the world's first wireless pacemaker device.
FDA approves Ozempic to reduce risks from chronic kidney disease in diabetes patients
Ozempic, the blockbuster GLP-1 drug that was originally approved to treat type 2 diabetes, has now also been approved by the ...
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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 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 ...
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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 ...