FDA to withdraw certain drug-related guidances with end of PHE
By
Alicia Lasek
Mar 14, 2023
The Food and Drug Administration has issued a notice detailing which COVID-19-related guidances will expire when the public health emergency ends as scheduled on May 11, and which guidances will remain...
Start-up gains FDA clearance to track Parkinson’s symptoms using Apple Watch
By
Alicia Lasek (f3)
Jun 15, 2022
Clinicians can use the data provided by StrivePD software via Apple Watch to help Parkinson’s patients manage their symptoms, its developer says.
Clinical briefs for Thursday, March 17
By
Alicia Lasek
Mar 17, 2022
FDA to host public workshop addressing gaps in opioid prescriber education content … Frailty in rheumatoid arthritis reversible with treatment and exercise … FDA approves Symbicort aerosol generic...
Feds gauging threat to vaccine, test and treatment efficacy in face of omicron variant
By
Alicia Lasek
Dec 01, 2021
The United States is prepared to address any potential threat to the effectiveness of COVID-19 vaccines, tests and treatments posed by the new variant, according to the White House and federal health officials.
Boosters on the way: LTC residents, healthcare workers may top fed’s list after CDC approves 3rd shot
By
Alicia Lasek
Aug 16, 2021
The Biden administration has secured 100 million COVID-19 vaccine doses as part of a strategy to provide additional shots to already vaccinated priority groups this fall, investigators have been told....
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.
Feds wait for lowered vaccine efficacy to recommend COVID-19 booster shots
By
Alicia Lasek
Jul 22, 2021
COVID-19 vaccine booster shots will not be necessary until mRNA vaccines become less effective, federal health officials say. But immunocompromised Americans are potential near-term recipients, they told...
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...
FDA approves first generic of glucagon to treat severe low blood sugar
By
Alicia Lasek
Jan 04, 2021
Glucagon to treat severe hypoglycemia is available in a generic formula for the first time in 20 years.
Clinical Briefs for Monday, April 13
By
Alicia Lasek
Apr 12, 2020
More than 2,200 COVID-19 deaths in nursing homes … Lack of data, testing puts residents at risk of coronavirus: provider survey … More evidence found that ultrasound can aid in delivering future Alzheimer’s...