The Food and Drug Administration approved its first biosimilar product last week, opening the door for more costly drug alternatives.
Novavax applies for FDA authorization of its protein-based COVID shot
By
Amy Novotney
Feb 02, 2022
Biotech firm Novavax disclosed Monday that it had submitted its long-awaited application to the U.S. Food and Drug Administration for an emergency use authorization for its COVID-19 vaccine in the United...
FDA advisers recommend Moderna COVID booster for seniors, others at high risk
By
Alicia Lasek
Oct 15, 2021
In a unanimous vote, advisers agreed that vulnerable Moderna vaccine recipients should be offered a third shot. A half dose will be effective and will help protect against side effects, the drugmaker says.
FDA accelerates timetable for full approval of Pfizer vaccine
By
Danielle Brown
Aug 05, 2021
It may soon be “go” time for providers that have thus far held off on mandating COVID-19 vaccines for staff members, basing their decisions on the fact vaccines have been approved by the Food and...
FDA approves $5 rapid-results COVID antigen test
By
Alicia Lasek
Aug 28, 2020
The test involves a credit-card-sized device that functions like some pregnancy tests. The developer expects to begin shipping large quantities in September.
FDA alerts providers to lack of sterility in NuVision Pharmacy products
May 21, 2013
The Food and Drug Administration expanded an alert about NuVision Pharmacy of Dallas, TX, on Saturday. It said investigators found poor sterile production practices that raised concern about a lack of...
FDA moves to discard hearing aid prescription rule in favor of OTC devices
By
Alicia Lasek
Oct 20, 2021
Adults with mild to moderate hearing loss would be able to obtain certain air-conduction hearing aids without a prescription under a new proposed rule. Whether this change would benefit long-term care...
Medicare would cover breakthrough technology quicker under CMS proposal
By
Danielle Brown
Sep 01, 2020
Nursing home residents would have more access to new and breakthrough technology as treatment options under a new Medicare coverage pathway proposed by the federal health officials.
Assisted living residents with dementia receiving too many antipsychotics, GAO says
By
John Hall
Mar 03, 2015
Government investigators are calling for greater scrutiny of antipsychotics use among dementia patients in post-acute settings beyond nursing homes.
FDA approves first biosimilar insulin product
Jul 29, 2021
Semglee (insulin glargine-yfgn) is biosimilar to and interchangeable with Lantus (insulin glargine), provides cost-effective option