article thumbnail

FDA AdCom votes in favour of Lundbeck’s/Otsuka’s Rexulti in AAD

Pharmaceutical Technology

The current unmet need, the benefit of treatment with Rexulti, and a reasonable safety profile persuaded Dr. Merit Cudkowicz, Julieanne Dorn professor of neurology at Harvard University’s Medical School, to give a positive vote. Rexulti is an atypical antipsychotic.

FDA 96
article thumbnail

COVID At-Home Antigen Tests: If at First You Don’t Succeed Try, Try and Try Again

The FDA Law Blog

Ironically, a recent FDA safety communication points to a potential way out of this dilemma. In this safety communication, FDA advises the public as follows: If you test negative and have COVID-19 symptoms , you test again 48 hours later for a total of two tests.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Antidepressants and Suicide: Why Don’t People Think There’s a Link?

The People's Pharmacy

Physicians associated with the Department of Psychiatry at Harvard Medical School reported on six patients who suddenly developed an: “intense violent suicidal preoccupation after 2-7 weeks of fluoxetine [Prozac] treatment.” . “But in February 1990 an article appeared in the American Journal of Psychiatry (Feb.

FDA 81
article thumbnail

Resourceful or risky? The UK’s controversial COVID-19 vaccine strategy

pharmaphorum

I DID NOT consent to receive an off-label drug with NO evidence of benefit with a single dose. The British Medical Association (BMA) also blasted the decision as “unreasonable and totally unfair”. Just received this email cancelling my 2nd dose of the Pfizer vaccine. On the basis of UK government guidance yesterday.

article thumbnail

Resourceful or risky? The UK’s controversial COVID-19 vaccine strategy

pharmaphorum

I DID NOT consent to receive an off-label drug with NO evidence of benefit with a single dose. The British Medical Association (BMA) also blasted the decision as “unreasonable and totally unfair”. Just received this email cancelling my 2nd dose of the Pfizer vaccine. On the basis of UK government guidance yesterday.

article thumbnail

Covid-19 vaccine success bolsters nanoparticle drug delivery research

Pharmaceutical Technology

In an email to this news service, João Conde, PhD, professor at NOVA Medical School, Universidade NOVA de Lisboa, said advances like the mRNA vaccines serve as a testament to the breakthroughs made by science over decades of research at the junction of genetics and nanomedicine. Please check your email to download the Report.