Following an investigational new drug application clearance from the FDA, a phase 1 trial plans to evaluate CD-001.

The Food and Drug Administration (FDA) has cleared an investigational new drug application for the novel treatment, APTN-101, ...

Recovery from addiction is a journey rather than a destination. As individuals transition from addiction to sobriety, they ...

adaptive behavior and tremor” and went ahead with filing a new drug application with the FDA. Applied had planned to ask for U.S. approval on the strength of biomarker data, only for the FDA to ...

A constitutional challenge to the Biden administration program enabling Medicare to negotiate lower prices for prescription ...

A drug currently used to treat HIV has also been found to dramatically reduce the risk of infection, significantly more than the primary option available for pre-exposure prophylaxis or PrEP.

A U.S. appeals court revived a lawsuit on Friday by healthcare and drug industry groups challenging the first-ever U.S. law ...

The National Academies of Sciences, Engineering, and Medicine are private, nonprofit institutions that provide expert advice on some of the most pressing challenges facing the nation and world. Our ...

Indies Pharma Jamaica Limited has made history as it became the first Jamaican company to get an ANDA (Abbreviated New Drug Application) approved by the United States Food and Drug Administration ...

Granting patents to US firm Gilead Sciences for lenacapavir could hinder global efforts to end AIDS & restrict access to ...

Developing advanced drug screening tools is crucial for the advancement of personalized medicine and the creation of more effective treatments. One organ receiving particular attention in this area is ...

Civil society organisations opposing the patent applications of US-based pharma major Gilead ... According to UNAIDS, this new HIV drug can offer hope of ending AIDS if all have access. Lenacapavir, ...