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 ...
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 ...
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 ...
Charlotte’s Web Founder Aims For FDA Approval Of Autism Spectrum Disorder Drug
Joel Stanley, the founder and former CEO of Charlotte’s Web, is leading an effort to achieve approval from the FDA for a ...
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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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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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FDA approves Ozempic to reduce risks from chronic kidney disease in diabetes patients
Ozempic, the drug that was originally approved to treat type 2 diabetes, has now also been approved by the FDA to reduce ...
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 ...
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Sarepta, Biogen drugs with accelerated approval under fire in FDA report
A report from the U.S. FDA's Office of Inspector General ... The report looked at 24 drugs that went through the accelerated approval process. It said that for 21 of them, "there was a consistent ...
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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.
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 ...