Articles related to FDA

Study: This meta-analysis includes 232 randomized, double-blind, placebo-controlled trials of drug monotherapy for major depressive disorder submitted to the FDA between 1979 and 2016, and comprises nearly 75,000 adult and child participants. Conclusion: Patients with depression are likely to improve substantially from acute treatment of their depression with drug or placebo. Although the mean effect of antidepressants is only a small improvement over placebo, the effect of active drug seems to increase the probability that any patient will benefit substantially from treatment by about 15%.

The Emergency Use Authorization (EUA) for Paxlovid has been revised to reflect the new prescribing authority given to state-licensed pharmacists. Under this revision, patients must now show health records within the last year, which needs to include bloodwork, as well as a list of their current medications, including any over-the-counter (OTC).

In 2019, the FDA warned that gabapentin might cause serious breathing difficulties when used with drugs that depress the central nervous system. The warning may have not been heeded, as overdose deaths in which gabapentin was detected doubled from 449 in the first quarter of 2019 to 959 in the second quarter of 2020.

Copiktra (duvelisib), an oral inhibitor of phosphoinositide 3-kinase (PI3K), is indicated for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least 2 prior therapies. Based on the results of a clinical trial evaluating the long-term effects of the drug, the FDA recommends that health care providers evaluate the risks and benefits of continuing Copiktra vs. prescribing an alternative therapy.

RhoVac AB’s RV001 (onilcamotide) was granted Fast Track designation by FDA based on positive performance in its phase I/II trial. Unfortunately, in the follow-on Phase IIb BRaVac trial, the drug failed to demonstrate superiority over the placebo.

In the study,155 FDA-approved drugs with 136 potentially targetable genes were identified.One-hundred forty-six (94%) of the drugs showed no or low genetically predicted drug response. Although ATC-carrying BRAF mutations can benefit from BRAF inhibitors and this effect might be enhanced by a combined strategy including PIK3CA inhibitors in some of the patients, alterations in BRAFWT ATC are not directly targeted by currently FDA-approved options.