Lundbeck has gained orphan drug designation (ODD) from Japan’s Ministry of Health, Labor and Welfare (MHLW) for amlenetug to ...

Treatments for autoimmune diseases and those in orphan markets are on the up and up, as are drugmakers’ first launches, ...

The FDA granted fast track designation to ATSN-201 for the treatment of X-linked retinoschisis, according to a press release ...

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Plus Therapeutics’ injectable ...

With orphan drugs typically being high value, the potential risk of stock losses should be a top concern for biotechs looking ...

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 ...

Lundbeck’ amlenetug receives Japanese orphan drug designation for treatment of multiple system atrophy: Denmark Tuesday, March 11, 2025, 11:00 Hrs [IST] H. Lundbeck A/S (Lundbec ...

EN001, a novel therapy under development by ENCell, has been granted Orphan Drug Designation by the U.S. FDA for the treatment of Charcot-Marie-Tooth (CMT) disease. Phase 1 clinical trial confirmed ...

The European orphan drug market is growing and is already comparable in size and scope to the US market. The European Union ...