In 1983, Congress passed the Orphan Drug Act (“ODA”) as part of an effort to provide market incentives for pharmaceutical manufacturers to produce “orphan drugs,” drugs for diseases that impact less ...

Non-profit organisations provide an alternative to rescue stalled orphan drugs for biotechs struggling against a lethargic investment climate.

ORLANDO, FL / ACCESS Newswire / April 1, 2025 / MARIJUANA INC. (OTC PINK:MAJI), dba Exousia Pro, Inc., a clinical-stage biotech company using exosomes in the treatment of cancer and other maladies, is ...

Swedish company Sigrid’s weight loss product has been recognised by the US Food and Drug Administration as a medical food.

The U.S. Food and Drug Administration (FDA) previously granted orphan drug designation to deucrictibant for the treatment of bradykinin-mediated angioedema in March 2022.

In 1983, the US Congress passed the Orphan Drug Act to encourage more pharmaceutical companies to engage in R&D to develop treatments for rare diseases through the offering of financial incentives.

However, with the advent of the 1983 Orphan Drug Act, the US government intervened by making it cost-worthy for pharma companies to develop these niche drugs. Pharma companies now benefit greatly ...

The US leads the world in rare disease research. Spurred by the Orphan Drug Act of 1983, there are 1303 US FDA-approved orphan drugs (ODs), with an estimated 7561 in development and 6.9 billion US ...

Congress should also pass The Orphan Cures Act, which would fix the misguided interpretation that only orphan drugs with a single approved indication are exempt from government price controls.

In the United States, orphan drugs are developed under the Orphan Drug Act (ODA), which supports treatments for diseases affecting fewer than 200,000 people. Similarly, in Europe, orphan medicines ...

Shares of Plus Therapeutics, Inc. PSTV were up a whopping 311.4% on March 6 after the company announced that the FDA has granted an Orphan Drug ... Prescription Drug User Fee Act (PDUFA) charge ...