The Latest Breaking News from FDA

Infectious omicron BA.2 now dominant in US, with coronavirus spring rise likely

LOS ANGELES — The highly infectious BA.2 omicron subvariant is now the dominant version of the coronavirus circulating in the United States, according to federal estimates, a development that is triggering fresh concerns of a potential springtime wave.

Los Angeles Times · Mar 29, 2022

How does the COVID-19 prevention drug Evusheld work and who should receive it? An infectious disease specialist explains

The U.S. Food and Drug Administration granted emergency use authorization to AstraZeneca’s COVID-19 antibody drug Evusheld on Dec. 8, 2021. Infectious disease physician Patrick Jackson of the University of Virginia explains how it works, who’s eligible and why some patients are having difficulties accessing it.

The Conversation · Mar 29, 2022

FDA Approves ViiV Healthcare's Cabenuva For Virologically Suppressed Adolescents With HIV

The FDA has approved ViiV Healthcare's Cabenuva (cabotegravir, rilpivirine) for HIV-1 in virologically suppressed adolescents. The approval covers patients aged 12 years or older and weighing at least 35kg on a stable antiretroviral regimen, with no history of treatment failure and no known or suspected resistance to either cabotegravir or rilpivirine. The regimen…

Benzinga · Mar 29, 2022

Antares Pharma's Oral Testosterone Treatment Scores FDA Approval

Antares Pharma Inc (NASDAQ:ATRS) has nabbed another FDA approval, and the Company's second involving testosterone. The Company announced FDA approval for Tlando (testosterone undecanoate), an oral treatment for testosterone replacement therapy indicated for deficiency or absence of endogenous testosterone or hypogonadism. The first time the Company got a testosterone product approved by…

Benzinga · Mar 29, 2022

Ocuphire Pharma's Shares Fall Despite Positive Data From Registrational Phase 3 Trial Of Nyxol

Ocuphire Pharma Inc (NASDAQ:OCUP) announced topline results from the second Phase 3 MIRA-3 trial of Nyxol to reverse pharmacologically-induced mydriasis (dilation of the pupil).  The trial met its primary endpoint, with 58% of subjects (study eye) treated with Nyxol returning to ≤ 0.2 mm of their baseline pupil diameter (PD) at 90 minutes…

Benzinga · Mar 29, 2022

US FDA approves second Covid booster for Americans 50 and older

Immunocompromised people also eligible for second booster, with CDC now to decide how and when such doses are offered

The Guardian - US · Mar 29, 2022

FDA clears way for millions to get additional COVID-19 boosters

U.S. regulators cleared second booster doses of COVID-19 vaccine from Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE for adults 50 and older, making millions more people eligible for the shots as concern grows about a potential new wave of infections.

Tribune News Service · Mar 29, 2022

FDA clears way for millions to get additional COVID-19 boosters

U.S. regulators cleared second booster doses of COVID-19 vaccine from Moderna Inc. and the partnership of Pfizer Inc. and BioNTech SE for adults 50 and older, making millions more people eligible for the shots as concern grows about a potential new wave of infections.

Tribune News Service · Mar 29, 2022

FDA approves another COVID booster for 50 and up

The Food and Drug Administration’s decision opens a fourth dose of the Pfizer or Moderna vaccines to those people at least four months after their previous booster.

Chicago Sun-Times · Mar 29, 2022

FDA approves another Pfizer, Moderna Covid booster for 50 and up

US regulators are allowing people 50 and older to get another booster dose of the Pfizer or Moderna Covid-19 vaccine

The Independent UK · Mar 29, 2022