On eve of Alzheimer’s drug decision, Congress critiques FDA for Aduhelm review failures
By
Alicia Lasek
Jan 03, 2023
An “atypical review process and corporate greed” factored into the FDA’s approval of Alzheimer’s drug Aduhelm in 2021, congressional investigators say. They recommend sticking to protocol...
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.
Lawmakers push FDA to take swift action on OTC hearing aids
By
Diane Eastabrook
Apr 12, 2022
A bipartisan team has introduced a bill that orders the FDA to stop dragging its feet and issue a final rule making over-the-counter hearing aids available to consumers.
FDA authorizes omicron-targeting vaccines as preferred COVID booster shots
By
Alicia Lasek
Sep 01, 2022
The FDA has authorized new, bivalent versions of Pfizer’s and Moderna’s COVID-19 vaccines to be used as booster shots. At the same time, the original monovalent versions are no longer authorized as...
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...
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.
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...
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...