FDA approves ‘first of its kind’ vagus nerve stroke rehab technology
By
Alicia Lasek
Aug 30, 2021
The prescription Vivistim System is designed to be used along with rehabilitation exercises in patients recovering from chronic ischemic stroke, the agency announced Friday.
Feds approve Regeneron’s antibody therapy as COVID-19 preventive
By
Alicia Lasek
Aug 03, 2021
REGEN-COV now can be used after exposure to the SARS-CoV-2 virus to prevent severe illness in people at high risk of poor outcomes from COVID-19.
New Alzheimer’s drug Aduhelm has no clinical benefit, panel of medical experts concludes
By
Alicia Lasek
Jul 21, 2021
The drug does not improve upon the current standard of care for Alzheimer’s disease, say advisers to the Institute for Clinical and Economic Review, a drug pricing watchdog.
FDA calls for investigation into its approval of controversial Alzheimer’s drug
By
Alicia Lasek
Jul 12, 2021
The acting chief of the Food and Drug Administration has called for an investigation into the events leading up to the approval of Biogen’s brain plaque-clearing dementia drug aducanumab (Aduhelm).
FDA limits use of new dementia drug Aduhelm to mild cognitive impairment only
By
Alicia Lasek
Jul 09, 2021
The FDA’s new label restricts Aduhelm’s use to Alzheimer’s patients with mild cognitive impairment or mild dementia, drugmaker Biogen announced Thursday.
FDA allows injections, reduced dose of COVID monoclonal antibody therapy
By
Alicia Lasek
Jun 08, 2021
An effective but arguably underused COVID-19 monoclonal antibody therapy now may be more accessible for long-term care facilities that aren’t equipped to deliver intravenous infusions.
FDA approves first drug to slow Alzheimer’s in controversial decision
By
Alicia Lasek
Jun 07, 2021
The evidence convincingly shows that aducanumab (Aduhelm) removes beta amyloid — a hallmark of Alzheimer’s — from the brain, slowing the disease’s progression and giving patients and families much-needed...
FDA OKs third antibody COVID therapy; variants spur new pause on another
By
Alicia Lasek
Jun 01, 2021
A new COVID-19 treatment made by GlaxoSmithKline now is the third monoclonal antibody therapy federally authorized to help prevent severe disease outcomes in high-risk patients. But gene variants are interfering...
Diabetes med Farxiga gets FDA nod as kidney failure treatment; drug cuts risk by 39 percent
By
Alicia Lasek
May 04, 2021
Farxiga, an SGLT2 inhibitor, was found to reduce the risk of worsening renal function or cardiovascular or renal death by 39% in patients with chronic kidney disease — with and without type 2 diabetes.
Feds pushing combo therapy treatments in LTC to combat new COVID variants
By
Danielle Brown
May 03, 2021
Federal health officials are urging long-term care and other providers to prioritize the use of combination monoclonal antibody therapies to treat COVID-19 after after researchers found them to be more...