First biosimilar approved by FDA to treat common eye degeneration in elders
By
Alicia Lasek
Sep 21, 2021
The Food and Drug Administration has approved a less expensive copy of the blockbuster drug Lucentis for treating age-related (wet) macular degeneration and several other eye conditions.
U.S. lawmakers ramp up scrutiny of FDA following agency’s approval of controversial Alzheimer’s drug
By
Alicia Lasek
Sep 07, 2021
The FDA is being asked to help explain how Aduhelm (aducanumab) met accelerated approval criteria when so many experts — including internal advisers — have flagged insufficient safety and efficacy...
With approval of Pfizer vaccine, half of unvaccinated poll respondents likely to get COVID shot
By
Alicia Lasek
Sep 01, 2021
Nearly 50% of unvaccinated Americans who have heard about the FDA’s approval say they will now “probably” or “definitely” consider getting the shot, according to a new Harris poll.
FDA approves first nerve-stimulation device to aid stroke recovery
Aug 27, 2021
Vivistim System is a prescription therapy for ischemic stroke patients who have moderate-to-severe difficulty moving their arms and hands
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.
Clinical briefs for Monday, Aug. 23
By
Alicia Lasek
Aug 23, 2021
FDA pushing to fully approve Pfizer COVID vaccine this week … Accessible strength training nearly equals effect of drugs in lowering blood pressure, experts find … Need for yearly COVID shot may not...
FDA may grant Pfizer vaccine full approval by Labor Day: report
By
Alicia Lasek
Aug 05, 2021
The nationwide rise in COVID-19 cases driven by the highly transmissible delta strain has spurred the agency move quickly, sources told The New York Times.
FDA approves another pneumococcal vaccine that’s effective in older adults
By
Alicia Lasek
Jul 21, 2021
Drugmaker Merck is encouraging the use of its new shot, Vaxneuvance, in older adults diagnosed with certain chronic medical conditions or who are immunocompromised.
NIH head says full Pfizer vaccine approval could come this summer
By
Kimberly Marselas
Jul 20, 2021
Waiting for full federal approval of Pfizer’s COVID-19 vaccine is no reason to delay protection, the director of the National Institutes of Health said Monday, but those still holding out for the end...
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).