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 ...
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FDA Drug Approvals
Mrs. Thomas’ pharmacist explained the generic process to her and she ... The U.S. Food and Drug Administration (FDA) has given approval to Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories ...
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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.
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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 ...
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 ...
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Amid takeover talk, SpringWorks scores FDA nod for rare genetic disease treatment Gomekli
Tuesday, the agency signed off on SpringWorks’ Gomekli (mirdametinib) as a treatment for the rare genetic disorder ...
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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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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 ...