FDA advisers endorse bivalent vaccine for all COVID mRNA shots
By
Alicia Lasek
Jan 27, 2023
A panel of experts on Thursday agreed that the bivalent COVID-19 vaccines should be used as both initial and booster shots, phasing out the original vaccines.
FDA OKs new insulin biosimilar for type 2 diabetes
By
Alicia Lasek
Jul 30, 2021
Semglee is a safe and more cost-effective alternative to the drug Lantus (insulin glargine), the agency announced Wednesday. Semglee does not need a prescriber’s input to be substituted at the pharmacy.
While FDA moves to halt mask reuse, N95 access remains spotty, report finds
By
Alicia Lasek
Apr 15, 2021
A new push to ensure that healthcare facilities stockpile single-use or reusable N95 respirators has arrived while some workers continue to lack access to the equipment and U.S. mask manufacturers can’t...
FDA set to approve two COVID-19 antiviral pills this week
By
Alicia Lasek
Dec 22, 2021
FDA is expected to grant emergency use authorization to two antiviral COVID-19 pills this week, possibly as early as today, according to Bloomberg News, citing sources familiar with the matter.
FDA no longer requires positive COVID-19 test to prescribe Paxlovid, Lagevrio
By
Alicia Lasek
Feb 01, 2023
The FDA on Wednesday made it easier for clinicians to prescribe these antiviral drugs in cases where transmission is evident and the patient is at high risk of severe illness.
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...
U.S. COVID-19 strategy must veer to protecting the vulnerable, experts say
By
Alicia Lasek
Mar 22, 2022
When planning for a future with COVID-19, some clinicians believe that the public health focus should turn from stopping transmission to protecting those most likely to become severely ill, according to...
Merck to seek emergency use for COVID-19 antiviral pill that cuts severe outcomes by 50 percent
By
Alicia Lasek
Oct 04, 2021
Molnupiravir has reduced COVID-19 deaths and hospitalizations by half in a new clinical trial. An orally delivered drug could offer unprecedented treatment convenience, the drug’s developers say.
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...