Due to the unmet medical demands of many rare diseases around the world, the number of orphan designated drugs (ODD) by regulatory agencies such as the FDA and EMA has increased in recent years.

Ariceum Therapeutics, a private biotech company based in Berlin, has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its proprietary ...

Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers, today announced that the U.S. Food ...

As we near the end of our “emerging markets” focus month, Chia Wen Lee and Betty Su share their thoughts on the status of orphan drugs in China ... a very small number of individuals.

However, “orphan drugs” provide hope by offering treatment options that improve their quality of life and potentially extend life expectancy. “Orphan” diseases affect small patient ...

DUBLIN--(BUSINESS WIRE)--The "Orphan ... number of regulatory frameworks aimed at fast-tracking the approval process for these treatments. As a result, regulatory bodies like the U.S. Food and ...

Zydus Lifesciences Ltd. said on Wednesday that the US Food and Drug Administration granted its underdevelopment drug Usnoflast the orphan drug designation, according to an exchange filing on Wednesday ...

225Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment of SCLC. The FDA has granted orphan drug designation (ODD) to 225 ...

Arbor Biotechnologies Inc.’s ABO-101 has been awarded orphan drug and rare pediatric disease designations by the FDA for the treatment of primary hyperoxaluria type 1 (PH1).

Graph 1: Assessment of the HTA outcome in France, Germany, England and Scotland of all orphan drugs that obtained an EMA approval between 2013-2019. N above each bar equals the number of drugs ...

PH1 leads to excess oxalate production, resulting in stone formation in the kidney. Credit: SewCreamStudio/Shutterstock. The US Food and Drug Administration (FDA) has ...